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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01515423 | Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia | PHASE3 | COMPLETED | 1,429 | — | — | May 1, 2012 | Mar 1, 2015 | May 2, 2016 | 174 | United States, Argentina +24 |
| NCT01529515 | A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia | PHASE3 | COMPLETED | 509 | — | — | May 1, 2012 | Apr 1, 2014 | May 11, 2016 | 53 | United States, Colombia +6 |
Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (\>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (\<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (\>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was \<=3 at randomization; had a score of \>=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.
Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method.
| Arm | Type | Description |
|---|---|---|
| Paliperidone palmitate 3-month (PP3M) | EXPERIMENTAL | A formulation of paliperidone palmitate with a 3-month injection interval |
| Paliperidone palmitate 1-month (PP1M) | ACTIVE_COMPARATOR | A formulation of paliperidone palmitate with a 1-month injection interval |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PP3M 175 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks. |
| PP3M 263 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every third month for 48 weeks. |
| PP3M 350 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every third month for 48 weeks. |
| PP3M 525 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every third month for 48 weeks. |
| Placebo (20% Intralipid) | DRUG | Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks. |
| PP1M 50 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks. |
| PP1M 75 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks. |
| PP1M 100 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks. |
| PP1M 150 mg eq. | DRUG | Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks. |
| Placebo (20% Intralipid emulsion) | DRUG | Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria. |
Inclusion Criteria: * Patients with schizophrenia for more than 1 year and whose symptoms are worsening in the opinion of the investigator * A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 120 * Signed informed consent * Women must not be pregnant, breastfeeding, an...