Schizophrenia
Conditions
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
Interventions
DRUGAripiprazole
Tablets, Oral, 15-30 mg, once daily, 140 weeks
DRUGOlanzapine
Capsule, Oral, 10-20 mg, once daily, 140 weeks
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean change in the PANSS Total Score | from baseline to Week 6 |
| The percentage of patients showing significant weight gain (a≥ 7% increase) | from baseline to Week 26 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline on PANSS-Positive Scale Total Score | at the end of study |
| Change from baseline on PANSS-Negative Scale Total Score | at the end of study |
| Mean change from baseline in PANSS-derived Brief Psychiatric Rating Scale (BPRS) Core Score | at the end of study |
| Change from baseline on the CGI-S Score | at the end of study |
| Percentage of responders (≥ 30% decrease in PANSS Total Score, or score of 1 or 2 on CGI-I) | at the end of study |
| Change from baseline on the MADRS | at the end of study |
| Safety and tolerability | at the end of study |
| Mean CGI-I Score | at the end of study |
| Change from baseline on PANSS Total Score | at the end of study |
Outcome results
None listed