Trials / Completed
CompletedNCT00484471
ABLE: Abilify in Bipolar Disorder for Long-term Effectiveness
A Double Blind, Randomized, Placebo Controlled Trial of Aripiprazole Plus Valproate in the Short-Term and Long-Term Treatment of Bipolar Disorder
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 127 (actual)
- Sponsor
- Korea Otsuka International Asia Arab · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To compare combination treatment of aripiprazole plus valproate versus valproate alone in the prevention of relapse in bipolar I disorder patients with symptomatic remission after 5-6 weeks open-label acute treatment with aripiprazole plus valproate for manic or mixed episode, with or without psychotic features.
Detailed description
Further study details as provided by Korea OIAA
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | aripiprazole | 15-30 mg/day aripiprazole, 22 weeks |
| DRUG | valproate | sufficient dose as determined by investigator to maintain the therapeutic level. |
| DRUG | placebo | placebo to aripiprazole, 22 weeks |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2011-11-01
- Completion
- 2012-11-01
- First posted
- 2007-06-11
- Last updated
- 2022-03-31
Locations
13 sites across 4 countries: Hong Kong, Philippines, Taiwan, Thailand
Source: ClinicalTrials.gov record NCT00484471. Inclusion in this directory is not an endorsement.