A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients
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|ClinicalTrials.gov Identifier: NCT00300846|
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : November 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: aripiprazole Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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.|
|Study Start Date :||December 2005|
|Primary Completion Date :||July 2007|
|Study Completion Date :||July 2007|
|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)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300846
Show 57 Study Locations
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|