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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04072575 | A Study of Paliperidone Palmitate 6-Month Formulation | PHASE3 | COMPLETED | 178 | — | — | Sep 19, 2019 | May 3, 2022 | Apr 29, 2025 | 30 | Argentina, Hong Kong +4 |
| NCT03345342 | A Study of Paliperidone Palmitate 6-Month Formulation | PHASE3 | COMPLETED | 841 | — | — | Nov 20, 2017 | May 8, 2020 | Apr 29, 2025 | 138 | United States, Argentina +19 |
Number of participants with relapse were reported. Relapse is defined as one or more of the following: a) Psychiatric hospitalization for schizophrenia (involuntary or voluntary admission to a psychiatric hospital for decompensation of the participant's schizophrenic symptoms); b) Emergency Department/Room/Ward visit due to a worsening of the participant's symptoms of schizophrenia, but a psychiatric hospitalization does not occur; c) The participant inflicts deliberate self-injury or exhibits violent behaviour resulting in suicide, clinically significant injury to him/herself or another person, or significant property damage; d) The participant has suicidal or homicidal ideation and aggressive behaviour that is clinically significant (in frequency and severity) in the investigator's judgment.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are those events if they started after administration of the first dose and until 183 days after the last dose of study medication.
Time to relapse is time between participant randomization in DB Phase and first documentation of relapse event by end of Month 12 of DB phase. Relapse is defined as: a) Psychiatric hospitalization; b) Positive and Negative Syndrome Scale (PANSS) total score: Increase of 25 percentage (%), 10 point increase in PANSS for 2 analysis separated by 3-7 days if score was greater than (\>) 40, less than or equal to (\<=)40; c) Participants inflicted knowing self-injury/shown violent behavior leading to suicide, clinically significant injury to him/herself or other person/property; d) Participants had suicidal/homicidal ideation/violent behavior that was clinically significant as per investigator; e) PANSS items P1- delusions, P2- conceptual disorganization, P3-hallucinatory behavior, P6- suspiciousness/ persecution, P7-hostility, G8-uncooperativeness: score: greater than or equal to (\>=)5, \>=6 for 2 analysis separated by 3-7 days on any items if maximum score for PANSS: \<=3 or 4, respectively.
| Arm | Type | Description |
|---|---|---|
| Paliperidone Palmitate 6 month(PP6M) | EXPERIMENTAL | Participants who enter the this open-label extension study immediately after completing Double-blind Phase Study R092670PSY3015 (previous study) will receive Paliperidone Palmitate 6 month (PP6M) intramuscular (IM) injections, dose will be selected based on the unblinded dose level ("moderate" or "higher") that the participant received during previous study. Participants in the "moderate" dose level will receive PP6M Dose 1 and "higher" dose level will receive PP6M Dose 2 during the open-label extension. The PP6M dose level may be adjusted (to Dose 1 or Dose 2) for every 6 month at Visits 3, 5, and 7, based on clinical judgment. Participants who enter this open-label extension study later (up to 3 months after they complete previous study) and were on a moderate or higher dose of PP3M (350 or 525 mg eq.) or PP1M (100 or 150 mg eq.) will receive initial dose of PP6M IM injection (Dose 1 or Dose 2) for every 6 months. |
| PP1M: Transition Phase | EXPERIMENTAL | Participants who previously have not achieved stability with moderate to higher doses of Paliperidone palmitate 1-month (PP1M) or Paliperidone palmitate 3-month (PP3M) will enter into a transition period of up to 4 months. During transition period participants will receive 1 to 5 injections of PP1M 50 to 100 milligrams equivalent (mg eq.). The participants who achieved stability (stability is defined as at least 3 months of injections with the last 2 doses being the same strength) with PP1M 100 mg eq. will precede from transition phase to maintenance phase. |
| PP1M/PP3M: Maintenance Phase | EXPERIMENTAL | All the participants will receive only 1 dose of PP1M 100 or 150 mg eq. or PP3M 350 or 525 mg eq. The participants will precede from maintenance phase to double-blind phase. |
| PP6M or Placebo: Double-Blind Phase | EXPERIMENTAL | Participants will receive intramuscular injection of PP6M in left gluteal muscle on Day 1 and right gluteal muscle on Day 183 with alternating placebo in right gluteal muscle on Day 92 and left gluteal muscle on Day 274. |
| PP3M: Double-Blind Phase | EXPERIMENTAL | Participants will receive intramuscular injections of PP3M at dose of 350 mg eq. or 525 mg eq. in left gluteal muscle on Day 1 and 274 and right gluteal muscle on Day 92 and 183. |
| Name | Type | Description |
|---|---|---|
| PP6M injection Dose 1 | DRUG | Participants will receive Dose 1 PP6M intramuscular (IM) injection at Visit 1 (Day) then once every 6 month up to 24 months. |
| PP6M injection Dose 2 | DRUG | Participants will receive Dose 2 PP6M IM injection at Visit 1 (Day) then once every 6 month up to 24 months. |
| PP6M | DRUG | Participants will receive intramuscular injection of PP6M. |
| PP3M 350 mg eq. | DRUG | Participants will receive intramuscular injection of PP3M 350 mg eq. |
| PP3M 525 mg eq. | DRUG | Participants will receive intramuscular injection of PP3M 525 mg eq. |
| PP1M | DRUG | Participants will receive intramuscular injection of PP1M 50 to 150 mg eq. |
| Placebo | OTHER | Participants will receive matching placebo. |
Inclusion Criteria: * Completed the Double-blind Phase of Study R092670PSY3015 without relapse and continue to be willing to be treated with paliperidone palmitate 6 month injection (PP6M) * Must, in the opinion of the investigator, be able to continue treatment at the same dose level (moderate or ...