Schizophrenia

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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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