Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00812058 | A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression | PHASE2 | COMPLETED | 180 | — | — | Nov 1, 2008 | Dec 1, 2010 | Jan 17, 2011 | 36 | United States |
| Arm | Type | Description |
|---|---|---|
| RG2417 | EXPERIMENTAL | Oral RG2417 taken twice daily for 8 weeks |
| Placebo | PLACEBO_COMPARATOR | Oral placebo taken twice daily for 8 weeks |
| Name | Type | Description |
|---|---|---|
| RG2417 | DRUG | 1g bid dose escalates to 2g bid for weeks 2-8. |
| Placebo | DRUG | Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets. |
Inclusion Criteria: * Bipolar I Disorder, most recent episode depressed * History of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms Exclusion Criteria: * Current manic, hypomanic or mixed episode * Rapid cycling bipolar disorder (4 or ...