drugset / Trial / NCT00194077
Study of Aripiprazole (Abilify) in Children With Symptoms of Mania
Phase 3
Completed
60 enrolled
University Hospitals Cleveland Medical Center
Bristol-Myers Squibb · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to look at the safety and effectiveness of aripiprazole (abilify) in children with bipolar disorder and to examine whether or not patients that respond to initial mood stabilization benefit from continued pharmacotherapy.
Timeline
- Start
- 2004-08
- Primary completion
- 2011-01
- Completion
- 2011-01
Publications
- Results Findling RL, Youngstrom EA, McNamara NK, Stansbrey RJ, Wynbrandt JL, Adegbite C, Rowles BM, Demeter CA, Frazier TW, Calabrese JR. Double-blind, randomized, placebo-controlled long-term maintenance study of aripiprazole in children with bipolar disorder. J Clin Psychiatry. 2012 Jan;73(1):57-63. doi: 10.4088/JCP.11m07104. Epub 2011 Nov 29.
- Findling RL, McNamara NK, Youngstrom EA, Stansbrey RJ, Frazier TW, Lingler J, Otto BD, Demeter CA, Rowles BM, Calabrese JR. An open-label study of aripiprazole in children with a bipolar disorder. J Child Adolesc Psychopharmacol. 2011 Aug;21(4):345-51. doi: 10.1089/cap.2010.0102. Epub 2011 Aug 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aripiprazole | Other / unclassified | 2 mg | — |
| Comparator | Aripiprazole | Other / unclassified | 5 mg | — |
| Comparator | Aripiprazole | Other / unclassified | 7 mg | — |
| Comparator | Aripiprazole | Other / unclassified | 10 mg | — |
| Comparator | Aripiprazole | Other / unclassified | 12 mg | — |
| Comparator | Aripiprazole | Other / unclassified | 15 mg | — |