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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00195780 | A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents | PHASE3 | COMPLETED | 227 | — | — | Feb 1, 2005 | - | Jul 2, 2007 | 29 | United States |
| Name | Type | Description |
|---|---|---|
| Divalproex Sodium (Depakote ER) | DRUG | - |
Inclusion Criteria: * Subject is between 10 and 17 years of age, inclusive, on Day 1 and weighs at least 60 lbs (27 kg). * Subject has a current psychiatric diagnosis of bipolar I disorder, manic or mixed episode, based on the K-SAD-PL interview and DSM-IV-TR criteria. * Subject is an outpatient in...