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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00712686
• Date of registration: 08/07/2008
• Primary sponsor: Bristol-Myers Squibb
• Public title: Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia
• Scientific title: A Multicenter, Double-Blind, Randomized, Comparative Study of Aripiprazole and Olanzapine in the Treatment of Patients With Acute Schizophrenia
• Date of first enrolment: June 2000
• Target sample size: 690
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00712686
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Aripiprazole

Drug: Olanzapine

Primary Outcome(s)

The mean change in the PANSS Total Score [Time Frame: from baseline to Week 6]

The percentage of patients showing significant weight gain (a= 7% increase) [Time Frame: from baseline to Week 26]

Secondary Outcome(s)

Change from baseline on PANSS Total Score [Time Frame: at the end of study]

Change from baseline on PANSS-Negative Scale Total Score [Time Frame: at the end of study]

Change from baseline on PANSS-Positive Scale Total Score [Time Frame: at the end of study]

Change from baseline on the CGI-S Score [Time Frame: at the end of study]

Change from baseline on the MADRS [Time Frame: at the end of study]

Mean CGI-I Score [Time Frame: at the end of study]

Mean change from baseline in PANSS-derived Brief Psychiatric Rating Scale (BPRS) Core Score [Time Frame: at the end of study]

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]

Safety and tolerability [Time Frame: at the end of study]

Secondary ID(s)

CN138-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors