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Completed

NCT Number: NCT02192723

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

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.

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing HuiLongGuan Hospital

Beijing, 100096, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Typical antipsychotic

Drug

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

Other names: Haldol and Trilafon

Risperidone

Drug

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

Other names: Risperdal

Olanzapine

Drug

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

Other names: Zyprexa

Quetiapine

Drug

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

Other names: Seroquel

Aripiprazole

Device

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

Other names: Abilify

Ziprasidone

Drug

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

Other names: Geodon

Primary outcomes

  1. Positive and Negative Syndrome Scale (PANSS)

    Time frame: Baseline, 8 weeks

Secondary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Beijing HuiLongGuan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 17, 2014
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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