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

Information source: Beijing Hui-Long-Guan Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Typical antipsychotic (Drug); Risperidone (Drug); Olanzapine (Drug); Quetiapine (Drug); Aripiprazole (Device); Ziprasidone (Drug)

Phase: N/A

Status: Completed

Sponsored by: Beijing Hui-Long-Guan Hospital

Official(s) and/or principal investigator(s):
Zhi-Ren Wang, MD, PhD, Study Director, Affiliation: Beijing Hui-Long-Guan Hospital

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Positive and Negative Syndrome Scale (PANSS)

Secondary outcome: Clinical Global Impression (CGI)

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.

Eligibility

Minimum age: 25 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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 and Contacts

Beijing HuiLongGuan Hospital, Beijing 100096, China
Additional Information

Starting date: June 2012
Last updated: July 16, 2014

Page last updated: August 23, 2015

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