A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients
The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia.|
- Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine.
- The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
- Efficacy (PANSS, CGI)
- Effectiveness (IAQ, GAF)
- Patient Reported Outcomes
|Study Start Date:||December 2005|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
|Active Comparator: A1||
Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).
Other Name: Abilify
|Placebo Comparator: A2||
Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300846
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|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|