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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Aripiprazole
Olanzapine
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    A1

    B1

    Arm Description

    Outcomes

    Primary Outcome Measures

    The mean change in the PANSS Total Score
    The percentage of patients showing significant weight gain (a≥ 7% increase)

    Secondary Outcome Measures

    Change from baseline on the CGI-S Score
    Change from baseline on PANSS Total Score
    Change from baseline on PANSS-Positive Scale Total Score
    Change from baseline on PANSS-Negative Scale Total Score
    Mean change from baseline in PANSS-derived Brief Psychiatric Rating Scale (BPRS) Core Score
    Mean CGI-I Score
    Percentage of responders (≥ 30% decrease in PANSS Total Score, or score of 1 or 2 on CGI-I)
    Change from baseline on the MADRS
    Safety and tolerability

    Full Information

    First Posted
    July 8, 2008
    Last Updated
    November 7, 2013
    Sponsor
    Otsuka Pharmaceutical Development & Commercialization, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00712686
    Brief Title
    Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia
    Official Title
    A Multicenter, Double-Blind, Randomized, Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2000 (undefined)
    Primary Completion Date
    December 2003 (Actual)
    Study Completion Date
    December 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Otsuka Pharmaceutical Development & Commercialization, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    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
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    690 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A1
    Arm Type
    Active Comparator
    Arm Title
    B1
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Aripiprazole
    Other Intervention Name(s)
    Abilify
    Intervention Description
    Tablets, Oral, 15-30 mg, once daily, 140 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Olanzapine
    Intervention Description
    Capsule, Oral, 10-20 mg, once daily, 140 weeks
    Primary Outcome Measure Information:
    Title
    The mean change in the PANSS Total Score
    Time Frame
    from baseline to Week 6
    Title
    The percentage of patients showing significant weight gain (a≥ 7% increase)
    Time Frame
    from baseline to Week 26
    Secondary Outcome Measure Information:
    Title
    Change from baseline on the CGI-S Score
    Time Frame
    at the end of study
    Title
    Change from baseline on PANSS Total Score
    Time Frame
    at the end of study
    Title
    Change from baseline on PANSS-Positive Scale Total Score
    Time Frame
    at the end of study
    Title
    Change from baseline on PANSS-Negative Scale Total Score
    Time Frame
    at the end of study
    Title
    Mean change from baseline in PANSS-derived Brief Psychiatric Rating Scale (BPRS) Core Score
    Time Frame
    at the end of study
    Title
    Mean CGI-I Score
    Time Frame
    at the end of study
    Title
    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
    Title
    Change from baseline on the MADRS
    Time Frame
    at the end of study
    Title
    Safety and tolerability
    Time Frame
    at the end of study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bristol-Myers Squibb
    Organizational Affiliation
    Bristol-Myers Squibb
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18986646
    Citation
    Fleischhacker WW, McQuade RD, Marcus RN, Archibald D, Swanink R, Carson WH. A double-blind, randomized comparative study of aripiprazole and olanzapine in patients with schizophrenia. Biol Psychiatry. 2009 Mar 15;65(6):510-7. doi: 10.1016/j.biopsych.2008.07.033. Epub 2008 Nov 4.
    Results Reference
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    Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia

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