Trials / Completed
CompletedNCT00150553
Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder
A Phase IIIb, Randomized, Double-Blind, Parallel Group Study in Bipolar I Patients to Assess the Efficacy and Safety of SPD417 Administered Once Daily vs Twice Daily in the Treatment of Manic Symptoms
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 102 (planned)
- Sponsor
- Validus Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar manic symptoms, when given once daily in the evening vs. twice daily.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Extended-release carbamazepine |
Timeline
- Start date
- 2005-01-01
- Completion
- 2005-10-01
- First posted
- 2005-09-08
- Last updated
- 2007-11-02
Source: ClinicalTrials.gov record NCT00150553. Inclusion in this directory is not an endorsement.