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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02192723
• Other study ID #: Project863
• Status: Completed
• Phase: N/A
• First received: July 15, 2014
• Last updated: July 10, 2016
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: July 2016
• Source: Beijing HuiLongGuan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Typical antipsychotic
Haloperidol (6~20mg/day) and perphenazine (16~64mg/day), twice per day, 8 weeks
• Risperidone
2~6mg/day, twice per day, 8 weeks
• Olanzapine
Olanzapine, 400~750mg/day, twice per day, 8 weeks
• Quetiapine
Quetiapine, 400~750mg/day, twice per day, 8 weeks

Device:
• Aripiprazole
Aripiprazole, 10~30mg/day, twice per day, 8 weeks

Drug:
• Ziprasidone
Ziprasidone 80~160mg/day, twice per day, 8 weeks

Locations

Country	Name	City	State
China	Beijing HuiLongGuan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing HuiLongGuan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale	The UKU Side Effect Rating Scale is a comprehensive, clinician-rated scale, designed to assess the side effects in patients treated with psychotropic medications.	Baseline, 8 weeks	Yes
Primary	Positive and Negative Syndrome Scale (PANSS)		Baseline, 8 weeks	No
Secondary	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	No