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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02192723
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Xiang Yang Zhang, Beijing HuiLongGuan Hospital

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Typical antipsychotic Drug: Risperidone Drug: Olanzapine Drug: Quetiapine Device: Aripiprazole Drug: Ziprasidone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of 6 Antipsychotic Drugs in the Treatment of Acute Exacerbations of Chronic Inpatients With Schizophrenia: a Randomized Double-blind Study
Study Start Date : June 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014


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 Name: 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 Name: Risperdal

Active Comparator: Olanzapine
5~20mg/day
Drug: Olanzapine
Olanzapine, 400~750mg/day, twice per day, 8 weeks
Other Name: Zyprexa

Active Comparator: Quetiapine
400~750mg/day
Drug: Quetiapine
Quetiapine, 400~750mg/day, twice per day, 8 weeks
Other Name: 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 Name: 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 Name: Geodon




Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline, 8 weeks ]

Secondary Outcome Measures :
  1. Clinical Global Impression (CGI) [ Time Frame: Baseline, 8 weeks ]
    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


Other Outcome Measures:
  1. Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale [ Time Frame: Baseline, 8 weeks ]
    The UKU Side Effect Rating Scale is a comprehensive, clinician-rated scale, designed to assess the side effects in patients treated with psychotropic medications.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192723


Locations
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China
Beijing HuiLongGuan Hospital
Beijing, China, 100096
Sponsors and Collaborators
Beijing HuiLongGuan Hospital
Investigators
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Study Director: Zhi-Ren Wang, MD, PhD Beijing HuiLongGuan Hospital
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Responsible Party: Xiang Yang Zhang, Director, the Research Center, Beijing HuiLongGuan Hospital
ClinicalTrials.gov Identifier: NCT02192723    
Other Study ID Numbers: Project863
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Risperidone
Aripiprazole
Quetiapine Fumarate
Ziprasidone
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents
Dopamine Agonists
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists