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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00590577 | Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Patients With Schizophrenia | PHASE3 | COMPLETED | 652 | — | — | Mar 1, 2007 | Mar 1, 2008 | Jun 4, 2014 | 66 | United States, Malaysia +6 |
The PANSS measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Paliperidone palmitate 25 mg eq. Paliperidone palmitate 150 mg eq. i.m. Day 1 and 25 mg eq. i.m. Days 8 36 64 |
| 002 | EXPERIMENTAL | Paliperidone palmitate 100 mg eq. Paliperidone palmitate 150 mg eq. i.m. Day 1 and 100 mg eq. i.m. Days 8 36 64 |
| 003 | EXPERIMENTAL | Paliperidone palmitate 150 mg eq. Paliperidone palmitate 150 mg eq. i.m. Days 1 8 36 64 |
| 004 | PLACEBO_COMPARATOR | Placebo Placebo i.m. Days 1 8 36 64 |
| Name | Type | Description |
|---|---|---|
| Paliperidone palmitate 25 mg eq. | DRUG | Paliperidone palmitate 150 mg eq. i.m. Day 1 and 25 mg eq. i.m. Days 8, 36, 64 |
| Paliperidone palmitate 150 mg eq. | DRUG | Paliperidone palmitate 150 mg eq. i.m. Days 1, 8, 36, 64 |
| Placebo | DRUG | Placebo i.m. Days 1, 8, 36, 64 |
| Paliperidone palmitate 100 mg eq. | DRUG | Paliperidone palmitate 150 mg eq. i.m. Day 1 and 100 mg eq. i.m. Days 8, 36, 64 |
Inclusion Criteria: * Met diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) for at least 1 year before screening. Prior medical records, written documentation or verbal information obtained from previous psychiatric pro...