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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00257166 | Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed) | PHASE3 | COMPLETED | 238 | — | — | Jan 1, 2006 | Jul 1, 2007 | Mar 3, 2021 | 50 | United States |
YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.
| Arm | Type | Description |
|---|---|---|
| Ziprasidone oral capsules | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ziprasidone oral capsules | DRUG | Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID. |
| placebo oral capsules | DRUG | Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID. |
Inclusion Criteria: * DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years Exclusion Criteria: * Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for QT prolongation