Trials / Completed
CompletedNCT00812058
A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression
A Phase II Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Safety, Tolerability and Efficacy of RG2417 (Uridine) in the Treatment of Bipolar I Depression
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- Repligen Corporation · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test a new drug, RG2417, to see how the drug affects symptoms of bipolar I depression and to make sure it is safe in humans.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RG2417 | 1g bid dose escalates to 2g bid for weeks 2-8. |
| DRUG | Placebo | Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets. |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2010-12-01
- Completion
- 2010-12-01
- First posted
- 2008-12-19
- Last updated
- 2011-01-17
Locations
36 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00812058. Inclusion in this directory is not an endorsement.