A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode
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|ClinicalTrials.gov Identifier: NCT00094432|
Recruitment Status : Completed
First Posted : October 19, 2004
Last Update Posted : November 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Bipolar I Disorder||Drug: Aripiprazole Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||650 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Aripiprazole in the Treatment of Patients With Bipolar I Disorder With a Major Depressive Episode. CN138-146 LT is the 26-week Open Label Extension Phase of the Above Titled Protocol, CN138-146 ST.|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||November 2006|
|Actual Study Completion Date :||November 2006|
|Active Comparator: A1||
Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.
Other Name: Abilify
|Placebo Comparator: A2||
Tablets, Oral, 0 mg, Once daily, 8 weeks.
- Mean change from baseline to endpoint on the MADRS total score.
- Clinical Global Impression - Bipolar Version
- Severity of illness score depression
- Mean change from baseline to endpoint
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): NCT00094432
Show 40 Study Locations
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|