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

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Typical antipsychotic; Drug: Risperidone; Drug: Olanzapine; Drug: Quetiapine; Device: Aripiprazole; Drug: Ziprasidone

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.

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100096
    • Beijing HuiLongGuan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Typical antipsychotic; Haloperidol (6~20mg/day) and perphenazine (16~64mg/day) for 8 weeks.	Drug: Typical antipsychotic; Haloperidol (6~20mg/day) and perphenazine (16~64mg/day), twice per day, 8 weeks; Other Names: Haldol and Trilafon
Active Comparator: Risperidone; Risperidone, 2~6mg/day, twice day, 8 weeks	Drug: Risperidone; 2~6mg/day, twice per day, 8 weeks; Other Names: Risperdal
Active Comparator: Olanzapine; 5~20mg/day	Drug: Olanzapine; Olanzapine, 400~750mg/day, twice per day, 8 weeks; Other Names: Zyprexa
Active Comparator: Quetiapine; 400~750mg/day	Drug: Quetiapine; Quetiapine, 400～750mg/day, twice per day, 8 weeks; Other Names: Seroquel
Active Comparator: Aripiprazole; Aripiprazole, 10~30mg/day, twice per day, 8 weeks	Device: Aripiprazole; Aripiprazole, 10～30mg/day, twice per day, 8 weeks; Other Names: Abilify
Active Comparator: Ziprasidone; Ziprasidone, 80~160mg/day, twice per day, 8 weeks	Drug: Ziprasidone; Ziprasidone 80~160mg/day, twice per day, 8 weeks; Other Names: Geodon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive and Negative Syndrome Scale (PANSS)	Baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beijing HuiLongGuan Hospital
• Investigators: Study Director: Zhi-Ren Wang, MD, PhD, Beijing HuiLongGuan Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 17, 2014

Study Record Updates

• Last Update Posted (Estimate): July 12, 2016
• Last Update Submitted That Met QC Criteria: July 10, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Olanzapine; Aripiprazole; Quetiapine Fumarate; Risperidone; Ziprasidone; Antipsychotic Agents
• Other Study ID Numbers: Project863