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

Beijing HuiLongGuan Hospital

Status: Completed

Conditions: Schizophrenia

Treatments: Drug: Ziprasidone; Device: Aripiprazole; Drug: Typical antipsychotic; Drug: Risperidone; Drug: Olanzapine; Drug: Quetiapine

Study type: Interventional

Funder types: Other

Identifiers

NCT02192723

Project863

Details and patient eligibility

About

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.

Full 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.

Enrollment: 550 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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550 participants in 6 patient groups

Typical antipsychotic

Experimental group

Description:

Haloperidol (6\~20mg/day) and perphenazine (16\~64mg/day) for 8 weeks.

Treatment:

Drug: Typical antipsychotic

Risperidone

Active Comparator group

Description:

Risperidone, 2\~6mg/day, twice day, 8 weeks

Treatment:

Drug: Risperidone

Olanzapine

Active Comparator group

Description:

5\~20mg/day

Treatment:

Drug: Olanzapine

Quetiapine

Active Comparator group

Description:

400\~750mg/day

Treatment:

Drug: Quetiapine

Aripiprazole

Active Comparator group

Description:

Aripiprazole, 10\~30mg/day, twice per day, 8 weeks

Treatment:

Device: Aripiprazole

Ziprasidone

Active Comparator group

Description:

Ziprasidone, 80\~160mg/day, twice per day, 8 weeks

Treatment:

Drug: Ziprasidone