Clinical trial NCT00712686: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-10
Enrollment: 690
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: The mean change in the PANSS Total Score
timeFrame: from baseline to Week 6
measure: The percentage of patients showing significant weight gain (a≥ 7% increase)
timeFrame: from baseline to Week 26
Secondary outcomes:
measure: Change from baseline on the CGI-S Score
timeFrame: at the end of study
measure: Change from baseline on PANSS Total Score
timeFrame: at the end of study
measure: Change from baseline on PANSS-Positive Scale Total Score
timeFrame: at the end of study
measure: Change from baseline on PANSS-Negative Scale Total Score
timeFrame: at the end of study
measure: Mean change from baseline in PANSS-derived Brief Psychiatric Rating Scale (BPRS) Core Score
timeFrame: at the end of study
measure: Mean CGI-I Score
timeFrame: at the end of study
measure: Percentage of responders (≥ 30% decrease in PANSS Total Score, or score of 1 or 2 on CGI-I)
timeFrame: at the end of study
measure: Change from baseline on the MADRS
timeFrame: at the end of study
measure: Safety and tolerability
timeFrame: at the end of study
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
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.