| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01448720 | Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate | PHASE3 | COMPLETED | 142 | — | — | Sep 1, 2011 | Dec 1, 2013 | Sep 18, 2014 | 12 | Brazil, Colombia +1 |
| NCT01281527 | Paliperidone Palmitate Flexible Dosing in Schizophrenia | PHASE3 | COMPLETED | 1,044 | — | — | Nov 1, 2010 | Nov 1, 2013 | Mar 10, 2014 | 127 | Austria, Belgium +18 |
| NCT01258920 | A Study of Paliperidone Palmitate in Japanese Patients With Schizophrenia | PHASE3 | COMPLETED | 201 | — | — | Oct 1, 2010 | Nov 1, 2012 | Jun 24, 2014 | 29 | Japan |
| NCT01299389 | An Efficacy and Safety Study of Paliperidone Palmitate in Participants With Schizophrenia | PHASE3 | COMPLETED | 323 | — | — | Oct 1, 2010 | May 1, 2012 | Jun 17, 2013 | 56 | Japan, South Korea +1 |
| NCT01051531 | A Safety, Tolerability, and Treatment Response Study of Paliperidone Palmitate Administered to Patients With Schizophrenia | PHASE3 | COMPLETED | 546 | — | — | Apr 22, 2010 | May 17, 2013 | Oct 28, 2024 | 41 | Australia, China +7 |
| NCT01081769 | Prevention of Relapse With Injectable Paliperidone Palmitate Versus Oral Antipsychotics | PHASE3 | COMPLETED | 769 | — | — | Feb 1, 2010 | Feb 1, 2013 | Feb 18, 2015 | 94 | Austria, Belgium +23 |
| NCT00119756 | A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock Muscle in Patients With Schizophrenia | PHASE3 | COMPLETED | 253 | — | — | Jun 1, 2005 | Nov 1, 2006 | Jun 8, 2011 | - | — |
| NCT00210548 | A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia | PHASE3 | COMPLETED | 366 | — | — | Apr 1, 2005 | Jun 1, 2006 | Jun 8, 2011 | - | — |
| NCT00111189 | A Study of the Efficacy (Effectiveness) of Paliperidone Palmitate in the Prevention of Recurrence of the Symptoms of Schizophrenia. | PHASE3 | COMPLETED | 414 | — | — | Feb 1, 2005 | Feb 1, 2008 | Jun 20, 2014 | 55 | United States, Costa Rica +7 |
| NCT00210717 | A Study to Compare the Effectiveness and Safety of Flexibly Varied Doses of Paliperidone Palmitate and Risperidone in Treating Patients With Schizophrenia | PHASE3 | COMPLETED | 748 | — | — | Feb 1, 2005 | Apr 1, 2007 | Jun 8, 2011 | - | — |
| NCT00101634 | Efficacy and Safety of a Long Acting Anti-Psychotic Versus Placebo in Patients With Schizophrenia | PHASE3 | COMPLETED | 518 | — | — | Dec 1, 2004 | Mar 1, 2006 | Jun 8, 2011 | - | — |
| NCT00073320 | Intramuscular Injections of Paliperidone Palmitate in the Arm or Buttock of Subjects With Schizophrenia | PHASE3 | COMPLETED | 88 | — | — | Aug 1, 2003 | May 1, 2004 | Apr 27, 2010 | - | — |
| NCT01606254 | A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia | PHASE2 | COMPLETED | 56 | — | — | Jan 1, 2007 | Apr 1, 2008 | Jun 5, 2013 | 1 | Japan |
| NCT01942382 | A Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia | PHASE1 | COMPLETED | 76 | — | — | Apr 1, 2009 | Mar 1, 2010 | Sep 16, 2013 | - | — |
| NCT01110317 | A Study of Paliperidone Blood Concentrations in Patients With Schizophrenia After Administration of Paliperidone Palmitate | PHASE1 | COMPLETED | 49 | — | — | Jul 1, 2005 | Mar 1, 2006 | Apr 27, 2010 | - | — |
The neuropsychiatric symptoms of schizophrenia will be assessed using the 30-item PANSS, which provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each question is rated on a scale of 1 (absent) to 7 (extreme).
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.
Number of days from baseline (day 1 of core phase) to relapse as evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25 percent (%) from baseline in the Positive And Negative Syndrome Score (PANSS) total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator's judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 ("much worse") or 7 ("very much worse") on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose.
Number of participants with a relapse event with relapses evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25% from baseline in the PANSS total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator's judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 ("much worse") or 7 ("very much worse") on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose.
The pre-dose plasma concentration (Cpredose) at Day 8 is defined as the plasma concentration obtained before a dose is given on Day 8. The mean Cpredose at Day 8 was measured in nanogram per milliliter (ng/ml).
The Cpredose at Day 36 is defined as the plasma concentration obtained before a dose is given on Day 36. The mean Cpredose at Day 36 was measured in ng/ml.
The Cpredose at Day 64 is defined as the plasma paliperidone concentration obtained before a dose is given on Day 64. The mean Cpredose at Day 64 was measured in ng/ml.
The Cpredose at Day 92 is defined as the plasma paliperidone concentration obtained after the treatment interval of the study drug (that is 4 weeks) passed after the final dose (Day 92). The mean Cpredose at Day 92 was measured in ng/ml.
The Cmax is defined as maximum observed analyte concentration.
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
The AUCtau is a measure of the plasma paliperidone concentration from time zero to end of dosing interval. It is used to characterize drug absorption.
The Css av is defined as value of average analyte concentration at steady-state (after 4 Intramuscular Injections of Paliperidone Palmitate).
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 \[none, normal\]; 1 \[Very Mild\]; 2 \[Mild\]; 3 \[Moderate\]; 4 \[severe\]).
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
The Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) is a measure of the plasma paliperidone concentration from time zero to end of dosing interval. It is used to characterize drug absorption.
| Arm | Type | Description |
|---|---|---|
| Paliperidone palmitate | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Oral Antipsychotics | ACTIVE_COMPARATOR | oral antipsychotics daily treatment according to local label for maximally 24 months |
| 001 | EXPERIMENTAL | Paliperidone Palmitate 25, 50, 75 or 100 mg eq every 4 wk for up to 24 mo |
| 002 | PLACEBO_COMPARATOR | Placebo Placebo every 4 wk up to 24 mo |
| Paliperidone palmitate 50 mg | EXPERIMENTAL | Paliperidone palmitate 50 milligram (mg) intramuscular (into the muscle) injection on Days 1, 8, 36 and 64. |
| Paliperidone palmitate 100 mg | EXPERIMENTAL | Paliperidone palmitate 100 mg intramuscular injection on Days 1, 8, 36 and 64. |
| Paliperidone palmitate 150 mg | EXPERIMENTAL | Paliperidone palmitate 150 mg intramuscular injection on Days 1, 8, 36 and 64. |
| Paliperidone palmitate 150/ 50 mg | EXPERIMENTAL | Paliperidone palmitate 150 mg intramuscular injection on Day 1 and paliperidone palmitate 50 mg intramuscular injection on Days 8, 36 and 64. |
| Treatment A | EXPERIMENTAL | Participants will receive 4 injections of paliperidone palmitate 150 milligram in the deltoid muscle on Days 1, 8, 36, and 64. |
| Treatment B | EXPERIMENTAL | Participants will receive 4 injections of paliperidone palmitate 75 milligram in the deltoid muscle on Days 1, 8, 36, and 64. |
| Treatment C | EXPERIMENTAL | Participants will receive 4 injections of paliperidone palmitate 75 milligram in the gluteal muscle on Days 1, 8, 36, and 64. |
| Name | Type | Description |
|---|---|---|
| Paliperidone palmitate | DRUG | Type=exact number, unit=mg, number=150, 100, 75 mg equivalent (eq), form=suspension for injection, route=intramuscular use. One IM injection of 150 mq on Day 1, 100 mg eq. on Day 8 (+/- 4 days), and 75 mg eq. is recommended on Days 36, 64, and 92. |
| Placebo | DRUG | Matching Placebo will be given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64. Participants who complete double-blind period or discontinued early from double-blind period will have follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants will not receive any study drug during post-observational period. |
| paliperidone palmitate injection | DRUG | injection with 150 mg equivalent on Day 1, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter |
| oral antipsychotics | DRUG | daily treatment according to local label for maximally 24 months |
| paliperidone palmitate 100 mg | DRUG | Patients will receive a single paliperidone palmitate 100 mg equivalent injection in the gluteal or deltoid muscle on Day 1, 8, 36, and 64. |
Inclusion Criteria: * Be otherwise healthy on the basis of physical examination and vital signs at Screening (Baseline) and have a current diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for at least 1 year before screening and ...