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

N/ACompletedNCT02192723

Beijing HuiLongGuan Hospital550 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

550

Conditions

Schizophrenia

Interventions

Typical antipsychoticDRUG

Haloperidol (6\~20mg/day) and perphenazine (16\~64mg/day), twice per day, 8 weeks

RisperidoneDRUG

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

OlanzapineDRUG

Olanzapine, 400\~750mg/day, twice per day, 8 weeks

Eligibility

Sex: ALLMin age: 25 YearsMax age: 60 Years

Medical Language ↔ Plain English

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: \-

Locations (1)

Beijing HuiLongGuan Hospital

Beijing, China

Outcomes

Primary Outcomes

Positive and Negative Syndrome Scale (PANSS)

Time frame: Baseline, 8 weeks

Secondary Outcomes

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

Time frame: Baseline, 8 weeks

Data from ClinicalTrials.gov

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