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

Primary Purpose

Schizophrenia

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Typical antipsychotic

Risperidone

Olanzapine

Quetiapine

Aripiprazole

Ziprasidone

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept 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:

Sites / Locations

Beijing HuiLongGuan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Arm Label

Typical antipsychotic

Risperidone

Olanzapine

Quetiapine

Aripiprazole

Ziprasidone

Arm Description

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

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

5~20mg/day

400~750mg/day

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

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

Outcomes

Primary Outcome Measures

Positive and Negative Syndrome Scale (PANSS)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02192723

First Posted

July 15, 2014

Last Updated

July 10, 2016

Sponsor

Beijing HuiLongGuan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02192723

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing HuiLongGuan Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

550 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Typical antipsychotic

Arm Type

Experimental

Arm Description

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

Arm Title

Risperidone

Arm Type

Active Comparator

Arm Description

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

Arm Title

Olanzapine

Arm Type

Active Comparator

Arm Description

5~20mg/day

Arm Title

Quetiapine

Arm Type

Active Comparator

Arm Description

400~750mg/day

Arm Title

Aripiprazole

Arm Type

Active Comparator

Arm Description

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

Arm Title

Ziprasidone

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Typical antipsychotic

Other Intervention Name(s)

Haldol and Trilafon

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Risperidone

Other Intervention Name(s)

Risperdal

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Other Intervention Name(s)

Zyprexa

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Quetiapine

Other Intervention Name(s)

Seroquel

Intervention Description

Quetiapine, 400～750mg/day, twice per day, 8 weeks

Intervention Type

Device

Intervention Name(s)

Aripiprazole

Other Intervention Name(s)

Abilify

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ziprasidone

Other Intervention Name(s)

Geodon

Intervention Description

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

Primary Outcome Measure Information:

Title

Positive and Negative Syndrome Scale (PANSS)

Time Frame

Baseline, 8 weeks

Secondary Outcome Measure Information:

Title

Clinical Global Impression (CGI)

Description

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

Other Pre-specified Outcome Measures:

Title

Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale

Description

The UKU Side Effect Rating Scale is a comprehensive, clinician-rated scale, designed to assess the side effects in patients treated with psychotropic medications.

Time Frame

Baseline, 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhi-Ren Wang, MD, PhD

Organizational Affiliation

Beijing HuiLongGuan Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Beijing HuiLongGuan Hospital

City

Beijing

ZIP/Postal Code

100096

Country

China

12. IPD Sharing Statement

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

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