Trials / Completed
CompletedNCT00145470
12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)
A Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Continuing Lithium or Valproic Acid/Divalproex Sodium for the Treatment of an Acute Manic or Mixed Episode
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 326 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Asenapine | Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1. |
| DRUG | Placebo | Placebo fast dissolving SL tablets, BID |
Timeline
- Start date
- 2005-06-02
- Primary completion
- 2007-02-28
- Completion
- 2007-03-22
- First posted
- 2005-09-05
- Last updated
- 2024-05-21
- Results posted
- 2019-09-16
Source: ClinicalTrials.gov record NCT00145470. Inclusion in this directory is not an endorsement.