A Randomized Double-blind Trial With 6 Antipsychotic Drugs for Schizophrenia

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy and side effects of 6 commonly used antipsychotic drugs in the treatment of schizophrenia in a Chinese population.

Detailed Description
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The relative effectiveness of second-generation (atypical) antipsychotic drugs as compared with that of older agents has been incompletely addressed, though newer agents are currently used far more commonly. The investigators compared a first-generation antipsychotic, perphenazine or haloperidol, with several newer drugs in a double-blind study. METHODS: A total of 550 patients with schizophrenia were recruited at 4 Chinese sites and randomly assigned to receive perphenazine (16 to 64 mg per day) or haloperidol(6 t0 20mg per day), olanzapine (5 to 20 mg per day), quetiapine (400 to 750 mg per day), aripiprazole (10 to 30 mg per day) or risperidone (2 to 6.0 mg per day) for up to 8 weeks.

Official Title
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Effectiveness of 6 Antipsychotic Drugs in the Treatment of Acute Exacerbations of Chronic Inpatients With Schizophrenia: a Randomized Double-blind Study

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Typical antipsychotic
* Drug: Risperidone
* Drug: Olanzapine
* Drug: Quetiapine
* Device: Aripiprazole
* Drug: Ziprasidone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients' diagnoses is based on the results of the Structured Clinical Interview for DSM (SCID) using the criteria of the fourth edition of the Diagnostic and Statistical Manual (DSM-IV), physical exams and routine chemistry, and hematology laboratory tests. Attending-level psychiatrists will use a Chinese translation of the SCID to interview patients and their family members, who are given freedom to ask additional questions if respondents do not understand the standard probes. Patients must meet the following criteria: (1) diagnosis of schizophrenia; (2) duration of illness more than 2 years; (3) between 25 and 60 years of age; and (5) have NOT received antipsychotic medication for at least 1 month;(6) acute exacerbations of chronic inpatients. A complete medical history, electroencephalograms and electrocardiogram are obtained, and a physical examination and laboratory tests are performed at study entrance. None of the study participants have abnormal findings on these tests. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Typical antipsychotic<br>Haloperidol (6 20mg/day) and perphenazine (16 64mg/day) for 8 weeks. | Drug: Typical antipsychotic<br>* Haloperidol (6 20mg/day) and perphenazine (16 64mg/day), twice per day, 8 weeks<br>* Other names: Haldol and Trilafon;|
| Active Comparator: Risperidone<br>Risperidone, 2 6mg/day, twice day, 8 weeks | Drug: Risperidone<br>* 2 6mg/day, twice per day, 8 weeks<br>* Other names: Risperdal;|
| Active Comparator: Olanzapine<br>5 20mg/day | Drug: Olanzapine<br>* Olanzapine, 400 750mg/day, twice per day, 8 weeks<br>* Other names: Zyprexa;|
| Active Comparator: Quetiapine<br>400 750mg/day | Drug: Quetiapine<br>* Quetiapine, 400～750mg/day, twice per day, 8 weeks<br>* Other names: Seroquel;|
| Active Comparator: Aripiprazole<br>Aripiprazole, 10 30mg/day, twice per day, 8 weeks | Device: Aripiprazole<br>* Aripiprazole, 10～30mg/day, twice per day, 8 weeks<br>* Other names: Abilify;|
| Active Comparator: Ziprasidone<br>Ziprasidone, 80 160mg/day, twice per day, 8 weeks | Drug: Ziprasidone<br>* Ziprasidone 80 160mg/day, twice per day, 8 weeks<br>* Other names: Geodon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale (PANSS) |  | Baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression (CGI) | The Clinical Global Impression rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders | Baseline, 8 weeks |