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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00844922 | Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842) | PHASE2 | COMPLETED | 16 | — | — | Sep 1, 2005 | Jun 1, 2006 | Dec 31, 2014 | - | — |
| Arm | Type | Description |
|---|---|---|
| Org 34517 | EXPERIMENTAL | Org 34517 titrated to 900 mg daily for 2 weeks |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SCH 900636 | DRUG | Org 34517 300 mg on Day 1, 600 mg on Day 2, then 900 mg daily starting from Day 3. Subjects in this arm were also to continue the "usual treatment" for psychotic major depression. |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * have attended Screening, Baseline, Visit Day 15, Day 29 and Day 43 of previous trial 28130; * have a CGI of Severity score of 3 or greater at Day 43 of previous trial 28130 and at Day 1 of current trial 28133, or a lower score when the investigator is of the opinion that furth...