Schizophrenia

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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study will investigate adjunction pregnenolone for cognitive symptoms and negative symptoms in patients with schizophrenia and schizoaffective disorder.</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:603157c8a095287470bef3714d3ce59e' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Diagnosis: DSM-IV/DSM-IV TR schizophrenia or schizoaffective disorder;</li>\n<li>Gender: Males and Females;</li>\n<li>Age: 25-60;</li>\n<li>Caucasian or Non Caucasian;</li>\n<li>Capable of providing informed consent;</li>\n<li>Duration of illness equal to or greater than one year;</li>\n<li>No change in antipsychotic medication in the previous eight weeks, no change in antipsychotic dose in the previous four weeks;</li>\n<li>No benzodiazepine use in the past twelve hours prior to cognitive testing;</li>\n<li>The patient cohort will be enriched for cognitive symptoms (Composite BACS scores = 0-3 standard deviations below the mean, assessed at the screening visit).</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Subjects with a DSM-IV/DSM-IV TR diagnosis of alcohol or substance dependence (other than nicotine) within the last month;</li>\n<li>Subjects with a history of significant head injury/trauma, as defined by one or more of the following:\n<ol>\n<li>Loss of consciousness (LOC) for more than 1 hour,</li>\n<li>Recurring seizures resulting from the head injury,</li>\n<li>Clear cognitive sequelae of the injury,</li>\n<li>Cognitive rehabilitation following the injury;</li>\n</ol>\n</li>\n<li>Subjects with unstable medical illness or neurological illness (seizures, CVA);</li>\n<li>Patients with hormone-sensitive tumors (such as breast, uterine, or prostate cancer);</li>\n<li>Clinically significant abnormalities in physical examination , ECG, or laboratory assessments;</li>\n<li>Pregnant women or women of child-bearing potential, who are either not surgically-sterile or not using appropriate methods of birth control (serum beta-HCG will be performed at baseline, 4 weeks, and 8 weeks to exclude pregnancy);</li>\n<li>Women who are breast-feeding;</li>\n<li>ECT treatment within the last 3 months;</li>\n<li>Use of oral contraceptives or other hormonal supplementation such as estrogen. Although early studies suggested no effects on menstrual cycle, alterations in downstream metabolites of pregnenolone (such as estradiol) could theoretically impact the efficacy of oral contraceptives and/or estrogen replacement. Similarly, it is theoretically possible that pregnenolone could be metabolized to other steroids, resulting in hair, skin, or other steroid-related changes. Since we have determined in our prior study that pregnenolone administration does not result in downstream elevations in DHEA, DHEAS, estradiol, or testosterone, these possibilities may be unlikely;</li>\n<li>Current active suicidal and/or homicidal ideation, intent, or plan;</li>\n<li>Known allergy to study medication.</li>\n</ul>\n</p>', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:187658b89b9648095f0813c8651bdf76' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Phase II study in patients with acute exacerbation of schizophrenia. The primary objective is to evaluate the efficacy via the changes from baseline in the total Positive and Negative Syndrome Scale (PANSS) score of three fixed doses of JNJ-37822681 compared with placebo after 6 weeks\' treatment in patients with schizophrenia</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:9b437d533bf2c90ce5bb8ed4912f21ce' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:0a7edee716aae68dfe13be1f3390f3ab' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:d1f74fcfd70d035a810ff4054f901344' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Alcohol use (more than 33%) and smoking (80-90%) commonly occur together in patients with schizophrenia. Varenicline (ChantixTM) has been approved by the FDA as a medication for smoking cessation. Recent animal studies have shown that chronic varenicline administration decreased alcohol consumption. There are no human data available on the effectiveness of varenicline in alcohol-use disorders. The aim of the proposed pilot study is to find out whether varenicline treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence. The proposed pilot study will enroll a cohort of up to 30 subjects with schizophrenia or schizoaffective disorder and nicotine and alcohol dependence, who are receiving ongoing outpatient mental health treatment from community providers. Subjects will be randomly assigned to one of the two treatment groups (varenicline vs. placebo). Following a one week screening phase, participants will be seen on day 4, day 8, then weekly over an 8-week treatment period. One week supply of medication will be dispensed at each study visit, with the exception of the first week, when only 4 days supply will be given on 2 days (visit 1 and 2). One month after discontinuation of medication, a follow-up interview will be conducted. Varenicline and placebo will be dispensed in 0.5 mg and 1 mg color coded capsules. During the first 3 days of treatment, participants will take one 0.5 mg tablet of varenicline (or placebo) by mouth daily. If the medication is well-tolerated, the dose will be increased to 0.5 mg by mouth twice daily for 4 days. From day 8, the dose will be increased to the standard dosing schedule of 1 mg (1 tablet) by mouth twice daily. At the end of the 8th week, varenicline will be discontinued. A structured clinical psychiatric interview and physical exam will be performed at baseline, along with a urine drug screen, which will be repeated on week 8, and at 1 month follow-up. Blood tests (complete blood count, basic metabolic panel, liver function tests) will be performed at baseline, then monthly. During weekly study visits patients will undergo breath carbon-monoxide and breath alcohol testing, and they will answer questions about depression, smoking and alcohol use. Detailed assessment of psychiatric symptom severity (including neuropsychological testing) will be performed at baseline, at the end of the treatment phase (week 8). A functional MRI study will be performed at baseline and at the end of study to assess changes in blood flow, emotional processing and working memory related to varenicline treatment. In addition, genetic polymorphism of the &#945;4&#946;2 nicotinic acetylcholine receptor and gene expression changes related to drinking/smoking/psychosis and varenicline treatment will also be assessed. The primary objectives of the proposed study are two fold: first to determine the feasibility of conducting a similar study on a larger scale, and second to establish pilot data for determining the effect size for hypothesized treatment effects on alcohol and nicotine use based on objective tests and self report. These estimates will help inform the minimum sample size needed for a larger future trial.</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:62fceee977660c6901e9e284e071be47' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Males or females, ages 18 to 69, with a DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder, receiving outpatient psychiatric treatment</li>\n<li>Currently taking antipsychotic medication for at least 4 weeks (medication is prescribed, compliance assessed based on self-report and collateral information)</li>\n<li>Current DSM-IV diagnosis of Nicotine Dependence</li>\n<li>Current DSM-IV diagnosis of Alcohol Dependence</li>\n<li>Subject expresses a desire to cut down or quit smoking and drinking (based on assessment with contemplation ladder)</li>\n<li>An average of at least one pack of cigarettes per day (&gt;=20 cigarettes/day) over the 7 days prior to intake</li>\n<li>An average of at least 7 drinks over the 7 days prior to intake</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Inability to give adequate informed consent</li>\n<li>Currently taking sustained - release bupropion (Zyban) or receiving any other form of bupropion, such as Wellbutrin or Wellbutrin SR; receiving another form of pharmacological smoking cessation treatment (e.g., nicotine gum or patch); or participating in another structured, formal smoking cessation program.</li>\n<li>Currently taking naltrexone (ReVia), Campral or Antabuse</li>\n<li>Participation in a clinical trial less than 3 months prior to intake</li>\n<li>History of suicide attempt in the past year</li>\n<li>History of hospitalization due to suicidal ideation in the past year</li>\n<li>Suicidal ideation at baseline</li>\n<li>Known allergic reaction to varenicline</li>\n<li>Female patients of childbearing potential who are sexually active, not sterile, and who deny using a form of birth control.</li>\n<li>Female patients who are pregnant or nursing.</li>\n<li>Significant unstable medical problems (e.g. impaired renal function).</li>\n<li>Significant unstable psychiatric disorders.</li>\n<li>Subjects who do not attend all required screening appointments.</li>\n<li>Subjects who have pending legal proceedings whose outcome may lead to incarceration within 3 months of intake.</li>\n<li>Positive urine drug screen for cocaine, opioids or amphetamine at baseline</li>\n<li>Current DSM-IV diagnosis of Cocaine, Opioid or Cannabis Dependence (1 month prior to enrollment)</li>\n<li>Metal implants or devices (e.g. aneurysm clips, cochlear implants, neural stimulators, cardiac pacemakers)</li>\n<li>Weight over 250 lbs</li>\n<li>Claustrophobia</li>\n</ul>\n</p>', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:38b2d34dfb3e682c4f5c25df49e3af1d' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Improvement in cognition will be assessed using the standardized California Verbal Learning Test (CVLT). [&nbsp;Time&nbsp;Frame:&nbsp;8 weeks&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:3425dbf67b1d8a0e0c0050ff629c5678' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Improvement in negative symptoms will be assessed using the PANSS negative score. [&nbsp;Time&nbsp;Frame:&nbsp;8 weeks&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:416397ef21cf30335108342ade0e97af' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of this study is to evaluate the effects of nicotinic alpha-7 MEM 3454 on P50 sensory gating in patients with Schizophrenia. The hypothesis is that MEM 3454 will normalize the P50 ratio. Data produced in this study will provide useful information regarding the value of P50 as an efficacy biomarker, and provide evidence for the optimal dosing of MEM 3454 for additional P50 studies.</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:0a4ef049fc87c523b70b3f63ee21ea89' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&#8226; Investigate the safety and tolerability of MEM 3454 compared with placebo [&nbsp;Time&nbsp;Frame:&nbsp;all time points&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:2391c1c8f135a3686fe2b6fcec75412f' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&#8226; Determine whether MMN correlates with P50. [&nbsp;Time&nbsp;Frame:&nbsp;Pre-dose and day 1&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:06c5a18979ea6c125bb3d387e140c178' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of this study is to determine whether Org 25935 is more effective than placebo in improving negative symptoms in subjects with schizophrenia who are concurrently treated with a stable dose of a second generation antipsychotic.</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:1199144e8eb6965851b7058d6ba95d7c' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Multi-Center, Double-Blind, Flexible-Dose Efficacy Trial With Org 25935 Versus Placebo as Add-on Therapy in Subjects With Predominant, Persistent Negative Symptoms of Schizophrenia Treated With a Stable Dose of a Second Generation Antipsychotic</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:01c36ffed9f4b1d94355cbcb4e21bd89' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The primary features of schizophrenia are characterized by positive (irrational thoughts and/or behavior) and negative symptoms. Negative symptoms are the gross absence of normal behavior and emotions, and usually include a general lack of engagement, social withdrawal, and loss of goal-directed behavior. Negative symptoms may strongly affect daytime activities and quality of life. The effects of currently available antipsychotics on negative symptoms are not satisfactory and leave much room for improvement. Org 25935 is an investigational drug that may help to correct the above characteristics of schizophrenia by facilitating the messenger function of an amino acid in the brain, called glutamate. Preliminary data suggest that lowered glutamate levels in schizophrenia are associated with a failure to activate relevant areas in the forebrain and with prominent negative symptoms.</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:12cfd8b6dbfe83d3e019a91b1c541a86' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Clinical diagnosis of schizophrenia with predominant,</li>\n<li>Negative symptoms,</li>\n<li>Receiving stable treatment with one of the following antipsychotics: aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Subjects with overt positive symptoms,</li>\n<li>Extrapyramidal symptoms,</li>\n<li>Depressive symptoms,</li>\n<li>Suicidality, uncontrolled medical disease, or other psychiatric disorder other than schizophrenia as a primary diagnosis are excluded.</li>\n</ul>\n</p>', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:cd989e63ee8ee837e249d4049ea69e81' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This local registration study is to confirm the hypothesis of the efficacy, tolerability and safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in schizophrenia</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:b82b3c4b112a5b9e61107bec349aeb8e' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Randomized, Open Label, Rater Blind, Flexible Dose Multi-Center Study Comparing The Efficacy And Safety Of Intramuscular Ziprasidone With Haloperidol For Three Days In Patients With Agitation Of Schizophrenia</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:45b219c9ffdfdf28f746369294244606' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Male or female Chinese subjects aged 18-65 years (including 65) at screening.</li>\n<li>Subjects meeting the ICD-10 (Classification of Mental and Behavioral Disorders) criteria for schizophrenia (F20.X).</li>\n<li>Subjects who are in acute phase of schizophrenia and are appropriate to receive intramuscular medication for at least 3 days</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>History of clinically significant physical illness especially myocardial infarction, non compensatory heart failure etc.</li>\n<li>Subjects receiving an investigational agent in the previous 3 months prior to screening.</li>\n<li>Use of antipsychotic agents within 12 hours or parenteral benzodiazepines within 4 hours prior to randomization and during the study.</li>\n</ul>\n</p>', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:2ea7c825c56014bbb717655193868dc9' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The responder rates of BPRS agitation subscale score from baseline to the end of study [&nbsp;Time&nbsp;Frame:&nbsp;72 hours&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:e4002d9c4d982de7f8fd8c03d10494ea' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Secondary endpoints include end of study change from baseline in Behavioral Activity Rating Scale (BARS), and in BPRS agitation subscale score. [&nbsp;Time&nbsp;Frame:&nbsp;72 hours&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:c85094fe69b827aca387f9c3934daae8' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Score change from baseline to the end of study in CGI-I (Improvement) and CGI Severity (CGI-S) [&nbsp;Time&nbsp;Frame:&nbsp;72 hours&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:b1e6ed7ef0ebc11f051c0ae4c3dff666' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:373fe9f2fc8f667ece999ccc537df76b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Safety and tolerability evaluation [&nbsp;Time&nbsp;Frame:&nbsp;72 hours&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:373fe9f2fc8f667ece999ccc537df76b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8e4a380583571360ca1fa40ae9dd58a0' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To Risperidone, In Schizophrenic Patients Previously Treated In Study Bl-1020 Iib For A Maximum Of Six Weeks With Bl-1020 (High Dose, Low Dose), Risperidone Or Placebo</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:8e4a380583571360ca1fa40ae9dd58a0' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9166251d44847f9f9b3e3e7249fde602' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To Risperidone</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:9166251d44847f9f9b3e3e7249fde602' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ddb9ed93d2966bf15fc870e8c1d36dbc' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This is a six-week, randomized, double blind, multi-center, parallel group Extension to the BL-1020 IIb study. In this Extension Study in patients hospitalized with schizophrenia who were previously treated in the BL-1020 IIb study with BL-1020 (low dose: 10 mg/day; high dose: target dose 30 mg/day), risperidone (target dose: 8 mg/day) or placebo after experiencing an acute exacerbation of schizophrenia. Patients who completed the 6 week treatment period and/or all efficacy assessments in Study BL-1020 IIb are eligible to continue double-blind treatment in this optional 6 week Extension Study. Approximately 220 patients will be enrolled in this study: Treatment Group IE (n=82, 10 mg/day BL-1020); Treatment Group IIE (n=82: target dose 30 mg/day BL-1020); Treatment Group IIIE (n=55; target dose 8 mg/day risperidone). Study drug (BL-1020 or risperidone) will be administered orally, once daily, in a doubleblinded manner, during this six-week Extension Study</p>\n', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:ddb9ed93d2966bf15fc870e8c1d36dbc' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:feb18df8e17e14877afac8cdc1bed742' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ol>\n<li>Male or female, 18-65 years of age at the time of entry into the BL-1020 IIb study</li>\n<li>Has provided informed consent to participate in the Extension Study</li>\n<li>Has completed 6 weeks of treatment and/or completed all efficacy assessments in Study BL-1020 IIb</li>\n<li>Females must have negative serum pregnancy test, or be post-menopausal, or if fecund, must practice established methods of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device [IUD]) for at least two months prior to screening</li>\n<li>Females must use an established method of birth control (as above) AND a barrier method (condom, diaphragm, contraceptive foam) while taking study medication</li>\n<li>Has a caregiver or an identified responsible person (e.g., family member, social worker, nurse) who will support him/her to ensure compliance with the treatment and outpatient visits</li>\n<li>Is willing to comply with not taking any prohibited medications during participation in the study</li>\n<li>Successful completion of End of Study assessments from BL-1020 IIb</li>\n</ol>\n</p><p> Exclusion Criteria:\n<ol>\n<li>Is unwilling or unable to provide informed consent</li>\n<li>Is unwilling or unable, in the opinion of the Investigator, to comply with study instructions</li>\n<li>Has a medical condition that would put him/her at risk for continuing in the study</li>\n<li>Score &gt; 9 on Modified InterSePT Scale for Suicidal Thinking (Modified ISST)</li>\n<li>Tested positive for drugs of abuse during the initial 6 weeks of treatment (Study BL-1020 IIb)</li>\n<li>Has been non-compliant with the study medication dosing and/or study procedures during the initial 6 weeks of treatment in Study BL-1020 IIb</li>\n<li>Is judged by the PI to be inappropriate for the study</li>\n</ol>\n</p>', created = 1283572196, expire = 1283658596, headers = '', serialized = 0 WHERE cid = '1:feb18df8e17e14877afac8cdc1bed742' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:4e8f51f24f88adbca7cae046cb633048' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>STUDY OBJECTIVES: To determine whether the addition of L-arginine to treatment as usual (TAU) in schizophrenia further improves and enhances therapeutic efficacy (positive, negative and depressive symptoms) and effectiveness of antipsychotic treatment STUDY POPULATION: Patients diagnosed (DSM-IV criteria) with schizophrenia or schizoaffective disorder Total expected number of patients: 14 INVESTIGATIONAL COMPOUND: L-arginine capsules, 3 grams of L-arginine given twice a day (total daily dose of 6 grams/day) DURATION OF ACTIVE TREATMENT: 3 weeks followed by wash-out phase of 5 days and 3 weeks of second treatment phase (cross-over design) EVALUATION CRITERIA: Primary (efficacy) outcomes: PANSS scores. Secondary outcomes: Calgary Depression Scale for schizophrenia, CGI; AIMS, UKU-assessment of side-effects ASSESSMENT SCHEDULE: Treatment arm 1: Baseline, weeks: 1,2,3, wash-out phase; week 4, cross-over phase: treatment phase-2; weeks 5,6,7 STATISTICAL CONSIDERATIONS: Analysis of variance of outcome measures with treatment as the between-subject factor and pre- and post-treatment scores as within- subjects factors. DURATION OF STUDY PERIOD: Patient recruitment to be completed in 12 months, study full completion 18 months.</p>\n', created = 1283572197, expire = 1283658597, headers = '', serialized = 0 WHERE cid = '1:4e8f51f24f88adbca7cae046cb633048' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:317a5521f73e3df0326d02a9e7b47e5f' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>We are going to investigate whether genotypes of the HTR2C receptor are associated with the metabolic syndrome in patients taking clozapine.</p>\n', created = 1283572197, expire = 1283658597, headers = '', serialized = 0 WHERE cid = '1:317a5521f73e3df0326d02a9e7b47e5f' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cff1d7268d127342ea5dc8adc2e5eacb' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Cross-Sectional Study of the Association Between HTR2C Gene Polymorphisms and the Metabolic Syndrome in Patients With Schizophrenia Taking Clozapine More Than 1 Year</p>\n', created = 1283572197, expire = 1283658597, headers = '', serialized = 0 WHERE cid = '1:cff1d7268d127342ea5dc8adc2e5eacb' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:eea97c2803c77572b452cc93042f0abc' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The use of antipsychotics, especially clozapine and olanzapine is associated with metabolic side effects, which put patients with schizophrenia at risk for cardiovascular morbidity or diabetes. The prevalence of the metabolic syndrome was 53.8% of patients who taking clozapine. The high interindividual variability in antipsychotic-induced metabolic abnormalities suggests that genetic makeup is a possible determinant. The genotypes of the HTR2C receptor are suggested to have associations with the metabolic syndrome in patients using antipsychotics. We are going to investigate whether genotypes of the HTR2C receptor are associated with the metabolic syndrome in patients taking clozapine.</p>\n', created = 1283572197, expire = 1283658597, headers = '', serialized = 0 WHERE cid = '1:eea97c2803c77572b452cc93042f0abc' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0110ddeb3a16fa225eee6f196ff92dbd' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>age 18-65</li>\n<li>who can understand and sign the informed consent</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>who refuse to participate this study</li>\n</ul>\n</p>', created = 1283572197, expire = 1283658597, headers = '', serialized = 0 WHERE cid = '1:0110ddeb3a16fa225eee6f196ff92dbd' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:c8b4e8587f57563509f365a81ab56d7c' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Since side effects of antipsychotics, dopamine D2 receptor blockers, frequently occur in older patients with schizophrenia and the risk is dose dependent, clinical guidelines universally adovocate the use of lower doses. However, there is no report to test this dosing guideline with measurements of D2 receptor blockade caused by antipsychotics. In this study, dopamine D2 receptor occupancy will be measured, using Positron Emission Tomography (PET), in 12 patients aged 50 and older with schizophrenia-spectrum disorders before and after a gradual 40 % dose reduction of antipsychotics that was safely achieved in the past study while setting a target dose still above the lower limit of the dose range recommended in clinical guidelines, i.e. 1.25 mg/day, for older patients. Our goal is to relate changes in clinical outcome, including subjective and objective clinical ratings, to dopamine D2 receptor occupancy, and compare these results with the data for younger patients in the literature.</p>\n', created = 1283572197, expire = 1283658597, headers = '', serialized = 0 WHERE cid = '1:c8b4e8587f57563509f365a81ab56d7c' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:79ef3b29ecfbac5886cbd82abe43dd0f' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Tolerability of 40 % risperidone dose reduction and its relation to the % change in occupancy following dose reduction [&nbsp;Time&nbsp;Frame:&nbsp;intermittent&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283572197, expire = 1283658597, headers = '', serialized = 0 WHERE cid = '1:79ef3b29ecfbac5886cbd82abe43dd0f' in /persistent/html/includes/cache.inc on line 109.

Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia

Trial phase: 
Phase II
Recruitment status: 
Not yet recruiting

This study will investigate adjunction pregnenolone for cognitive symptoms and negative symptoms in patients with schizophrenia and schizoaffective disorder.

Background information
Trial ID: 
NCT00728728
Other unique IDs: 
MHBB-012-07F
Official title: 

Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia

Detailed description: 

 

Number to be enrolled: 
88 patients

PPhase II Study on Patients With Acute Exacerbation of Schizophrenia

Phase II study in patients with acute exacerbation of schizophrenia. The primary objective is to evaluate the efficacy via the changes from baseline in the total Positive and Negative Syndrome Scale (PANSS) score of three fixed doses of JNJ-37822681 compared with placebo after 6 weeks' treatment in patients with schizophrenia

Background information
Other unique IDs: 
CR014737

Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia

Trial phase: 
Phase IV
Recruitment status: 
Recruiting

The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.

Background information
Trial ID: 
NCT00727103
Other unique IDs: 
SUNY UMU IRBPHS #5656
Official title: 

Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia - a Double Blind, Placebo Controlled Trial

Detailed description: 

Alcohol use (more than 33%) and smoking (80-90%) commonly occur together in patients with schizophrenia. Varenicline (ChantixTM) has been approved by the FDA as a medication for smoking cessation. Recent animal studies have shown that chronic varenicline administration decreased alcohol consumption. There are no human data available on the effectiveness of varenicline in alcohol-use disorders. The aim of the proposed pilot study is to find out whether varenicline treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder.

Number to be enrolled: 
30 patients

A Single-Center, Double-Blind (DB) Study of MEM 3454 on P50 Sensory Gating and Mismatch Negativity in Schizophrenia Patients

The purpose of this study is to evaluate the effects of nicotinic alpha-7 MEM 3454 on P50 sensory gating in patients with Schizophrenia. The hypothesis is that MEM 3454 will normalize the P50 ratio. Data produced in this study will provide useful information regarding the value of P50 as an efficacy biomarker, and provide evidence for the optimal dosing of MEM 3454 for additional P50 studies.

Background information
Other unique IDs: 
MEM 3454-102

Adjuvant Treatment With a Glycine Uptake Inhibitor in Subjects With Chronic Schizophrenia (Study 172003)(COMPLETED)

Trial phase: 
Phase II
Recruitment status: 
Completed

The purpose of this study is to determine whether Org 25935 is more effective than placebo in improving negative symptoms in subjects with schizophrenia who are concurrently treated with a stable dose of a second generation antipsychotic.

Background information
Trial ID: 
NCT00725075
Other unique IDs: 
172003
P05695
Official title: 

A Multi-Center, Double-Blind, Flexible-Dose Efficacy Trial With Org 25935 Versus Placebo as Add-on Therapy in Subjects With Predominant, Persistent Negative Symptoms of Schizophrenia Treated With a Stable Dose of a Second Generation Antipsychotic

Detailed description: 

The primary features of schizophrenia are characterized by positive (irrational thoughts and/or behavior) and negative symptoms. Negative symptoms are the gross absence of normal behavior and emotions, and usually include a general lack of engagement, social withdrawal, and loss of goal-directed behavior. Negative symptoms may strongly affect daytime activities and quality of life. The effects of currently available antipsychotics on negative symptoms are not satisfactory and leave much room for improvement.

Number to be enrolled: 
246 patients
Acronym: 
GIANT

A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation

Trial phase: 
Phase III
Recruitment status: 
Recruiting

This local registration study is to confirm the hypothesis of the efficacy, tolerability and safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in schizophrenia

Background information
Trial ID: 
NCT00723606
Other unique IDs: 
A1281152
Official title: 

A Randomized, Open Label, Rater Blind, Flexible Dose Multi-Center Study Comparing The Efficacy And Safety Of Intramuscular Ziprasidone With Haloperidol For Three Days In Patients With Agitation Of Schizophrenia

Detailed description: 

 

Number to be enrolled: 
364 patients

Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020

Trial phase: 
Phase II
Recruitment status: 
Recruiting

A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To Risperidone, In Schizophrenic Patients Previously Treated In Study Bl-1020 Iib For A Maximum Of Six Weeks With Bl-1020 (High Dose, Low Dose), Risperidone Or Placebo

Background information
Trial ID: 
NCT00722176
Other unique IDs: 
BL-1020 IIb (Extension)
Official title: 

A Six-Week, Randomized, Double-Blind, Parallel Group Extension Study To Evaluate The Long-Term Safety, Tolerability, And Efficacy Of Low And High Doses Of Bl-1020 Compared To Risperidone

Detailed description: 

This is a six-week, randomized, double blind, multi-center, parallel group Extension to the BL-1020 IIb study. In this Extension Study in patients hospitalized with schizophrenia who were previously treated in the BL-1020 IIb study with BL-1020 (low dose: 10 mg/day; high dose: target dose 30 mg/day), risperidone (target dose: 8 mg/day) or placebo after experiencing an acute exacerbation of schizophrenia.

Number to be enrolled: 
220 patients

L-Arginine in Treatment as Usual in Schizophrenia

STUDY OBJECTIVES: To determine whether the addition of L-arginine to treatment as usual (TAU) in schizophrenia further improves and enhances therapeutic efficacy (positive, negative and depressive symptoms) and effectiveness of antipsychotic treatment STUDY POPULATION: Patients diagnosed (DSM-IV criteria) with schizophrenia or schizoaffective disorder Total expected number of patients: 14 INVESTIGATIONAL COMPOUND: L-arginine capsules, 3 grams of L-arginine given twice a day (total daily dose of 6 grams/day) DURATION OF ACTIVE TREATMENT: 3 weeks followed by wash-out phase of 5 days and 3 weeks of second treatment phase (cross-over design) EVALUATION CRITERIA: Primary (efficacy) outcomes: PANSS scores. Secondary outcomes: Calgary Depression Scale for schizophrenia, CGI; AIMS, UKU-assessment of side-effects ASSESSMENT SCHEDULE: Treatment arm 1: Baseline, weeks: 1,2,3, wash-out phase; week 4, cross-over phase: treatment phase-2; weeks 5,6,7 STATISTICAL CONSIDERATIONS: Analysis of variance of outcome measures with treatment as the between-subject factor and pre- and post-treatment scores as within- subjects factors. DURATION OF STUDY PERIOD: Patient recruitment to be completed in 12 months, study full completion 18 months.

Background information
Other unique IDs: 
CPAT7176

Polymorphism of the 5-HT2C Receptor Gene and Clozapine-Associated Metabolic Change in Schizophrenia

Recruitment status: 
Recruiting

We are going to investigate whether genotypes of the HTR2C receptor are associated with the metabolic syndrome in patients taking clozapine.

Background information
Trial ID: 
NCT00717509
Other unique IDs: 
snh003
Official title: 

Cross-Sectional Study of the Association Between HTR2C Gene Polymorphisms and the Metabolic Syndrome in Patients With Schizophrenia Taking Clozapine More Than 1 Year

Detailed description: 

The use of antipsychotics, especially clozapine and olanzapine is associated with metabolic side effects, which put patients with schizophrenia at risk for cardiovascular morbidity or diabetes. The prevalence of the metabolic syndrome was 53.8% of patients who taking clozapine. The high interindividual variability in antipsychotic-induced metabolic abnormalities suggests that genetic makeup is a possible determinant. The genotypes of the HTR2C receptor are suggested to have associations with the metabolic syndrome in patients using antipsychotics.

Number to be enrolled: 
150 patients

Benefits of Optimizing Antipsychotic Doses and Their Relationship to Dopamine D2 Receptor Occupancy in Older Persons With Schizophrenia

Since side effects of antipsychotics, dopamine D2 receptor blockers, frequently occur in older patients with schizophrenia and the risk is dose dependent, clinical guidelines universally adovocate the use of lower doses. However, there is no report to test this dosing guideline with measurements of D2 receptor blockade caused by antipsychotics. In this study, dopamine D2 receptor occupancy will be measured, using Positron Emission Tomography (PET), in 12 patients aged 50 and older with schizophrenia-spectrum disorders before and after a gradual 40 % dose reduction of antipsychotics that was safely achieved in the past study while setting a target dose still above the lower limit of the dose range recommended in clinical guidelines, i.e. 1.25 mg/day, for older patients. Our goal is to relate changes in clinical outcome, including subjective and objective clinical ratings, to dopamine D2 receptor occupancy, and compare these results with the data for younger patients in the literature.

Background information
Other unique IDs: 
156/2007
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