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
About this trial
This is an interventional treatment trial for Schizophrenia
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
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
NCT ID
NCT00712686
First Posted
July 8, 2008
Last Updated
November 7, 2013
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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.
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Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia
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