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Completed

NCT Number: NCT00712686

Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia

The purpose of this study is to compare the efficacy and tolerability of aripiprazole to olanzapine over 26 weeks for the treatment of schizophrenia

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with DSM-IV diagnosis of schizophrenia patients in acute relapse
  • Treated as outpatients for at least one continuous 3-month period during the past 12 months
  • PANSS total score ≥60
  • Previously responsive to neuroleptics (other than clozapine)
  • Able to give informed consent and comprehend and satisfactorily comply with the protocol requirements

Exclusion criteria

  • An Axis I (DSM-IV) diagnosis of schizoaffective disorder
  • A clinical picture and/or history that was consistent with: (a) Delirium, dementia, amnestic or other cognitive disorders; (b) Bipolar disorder; (c)personality disorder
  • Nonresponsive to prior olanzapine therapy
  • Likely to require prohibited concomitant therapy
  • DSM-IV criteria for any significant substance abuse within the past three months, including addiction to cocaine or alcohol
  • Known to be allergic or hypersensitive to study drugs
  • Represented a significant risk of committing suicide based on history or mental status exam
  • Unstable thyroid pathology and treatment within the past six months
  • A history or evidence of a medical condition that would expose the patient to an undue risk
  • Clinically significant abnormal laboratory test results (including urine drug screen), vital sign, or ECG findings

Treatment and study plan

Aripiprazole

Drug

Tablets, Oral, 15-30 mg, once daily, 140 weeks

Other names: Abilify

Olanzapine

Drug

Capsule, Oral, 10-20 mg, once daily, 140 weeks

Primary outcomes

  1. The mean change in the PANSS Total Score

    Time frame: from baseline to Week 6

  2. The percentage of patients showing significant weight gain (a≥ 7% increase)

    Time frame: from baseline to Week 26

Secondary outcomes

  1. Change from baseline on the CGI-S Score

    Time frame: at the end of study

  2. Change from baseline on PANSS Total Score

    Time frame: at the end of study

  3. Change from baseline on PANSS-Positive Scale Total Score

    Time frame: at the end of study

  4. Change from baseline on PANSS-Negative Scale Total Score

    Time frame: at the end of study

  5. Mean change from baseline in PANSS-derived Brief Psychiatric Rating Scale (BPRS) Core Score

    Time frame: at the end of study

  6. Mean CGI-I Score

    Time frame: at the end of study

  7. Percentage of responders (≥ 30% decrease in PANSS Total Score, or score of 1 or 2 on CGI-I)

    Time frame: at the end of study

  8. Change from baseline on the MADRS

    Time frame: at the end of study

  9. Safety and tolerability

    Time frame: at the end of study

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia

Important dates

Study start
2000
Primary completion
2003
Study completion
2003
First posted
Jul 10, 2008
Registry last updated
Nov 8, 2013

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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