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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00132678 | A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes | PHASE3 | COMPLETED | 559 | — | — | Feb 1, 2005 | Dec 1, 2007 | Jul 29, 2013 | 51 | United States, Austria +8 |
| NCT00094926 | A Study of Effectiveness and Safety of Risperdal CONSTA Added to Usual Treatment in Patients With Bipolar Disorder Who Have Frequent Mood Episodes. | PHASE3 | COMPLETED | 275 | — | — | May 1, 2004 | Feb 1, 2007 | May 19, 2011 | - | — |
Mood Relapse was defined as: The subject met DSM-IV criteria for a manic, hypomanic, mixed, or depressive episode; or, the subject needed treatment intervention with any mood stabilizer, antipsychotic medication (other than study drug), benzodiazepine (beyond the dosage allowed), or antidepressant medication; or the subject required hospitalization for any bipolar mood episode; or the subject had a YMRS or MADRS score \>12 or a CGI-S score \>4; or a dose increase, or supplementation with oral risperidone or another antipsychotic or mood stabilizer, was needed in the opinion of the investigator.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Risperdal Consta 12.5 25 37.5 or 50mg intramuscular (IM) injection every 2 weeks |
| 002 | PLACEBO_COMPARATOR | Placebo Matching placebo intramuscular (IM) injection every 2 weeks |
| Name | Type | Description |
|---|---|---|
| Risperdal Consta | DRUG | 12.5, 25, 37.5 or 50mg intramuscular (IM) injection every 2 weeks |
| Placebo | DRUG | Matching placebo intramuscular (IM) injection every 2 weeks |
Inclusion Criteria: * Diagnosis of bipolar 1 disorder, currently experiencing a mixed or manic episode or stable * Two or more bipolar mood episodes in the last 2 years excluding current episode * Negative pregnancy test Exclusion Criteria: * History of \> than 4 mood episodes a year during the l...