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

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Risperidone; Drug: Quetiapine; Device: Aripiprazole; Drug: Typical antipsychotic; Drug: Olanzapine; Drug: Ziprasidone

• Registration Number: NCT02192723
• Lead Sponsor: Beijing HuiLongGuan Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-17
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-10
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risperidone	Risperidone	Risperidone, 2\~6mg/day, twice day, 8 weeks
Quetiapine	Quetiapine	400\~750mg/day
Aripiprazole	Aripiprazole	Aripiprazole, 10\~30mg/day, twice per day, 8 weeks
Typical antipsychotic	Typical antipsychotic	Haloperidol (6\~20mg/day) and perphenazine (16\~64mg/day) for 8 weeks.
Olanzapine	Olanzapine	5\~20mg/day
Ziprasidone	Ziprasidone	Ziprasidone, 80\~160mg/day, twice per day, 8 weeks

Primary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS)	Baseline, 8 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression (CGI)	Baseline, 8 weeks	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

Trial Locations

Locations (1)

Beijing HuiLongGuan Hospital; 🇨🇳 Beijing, China