A Phase 3 interventional study of Paliperidone palmitate (R092670) and Risperidone in Schizophrenia, sponsored by Xian-Janssen Pharmaceutical Ltd.. Completed at 8 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-10.
Sponsored by Xian-Janssen Pharmaceutical Ltd. · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the efficacy of paliperidone palmitate and risperidone long acting injection (LAI) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) along with safety and tolerability.
This is a randomized (assigned by chance), open-label (all people know the identity of the intervention), active-controlled, parallel-group (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter (when more than one hospital or medical school team work on a medical research study) comparative study in participants with schizophrenia. This study comprises a screening period of not more than 7 days and a 13-week open-label treatment period. Paliperidone palmitate will be administered as intramuscular injection (injection of a substance into a muscle) of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. at Day 8, flexible dose on Day 36 (50 or 100 mg eq.) and on Day 64 (50, 100 or 150 mg eq.) depending on investigator's discretion. Risperidone LAI will be administered at a dose of 25 mg at Day 8 and Day 22, flexible dose on Day 36 (25 or 37.5 mg) and Day 64 (25, 37.5, or 50 mg). Dose on Day 50 is the same as Day 36 and dose on Day 78 is the same as Day 64. Participants will receive oral risperidone tablets (1 to 6 mg/day) for the first 4 weeks of the open-label treatment period. Each participant may receive oral risperidone tablets (1 to 2 mg daily) for up to 3 weeks at Day 36 and Day 64 if the dose of risperidone LAI was increased on Day 36 and Day 64. Efficacy will primarily be assessed using the Positive and Negative Syndrome Scale (PANSS). Participants' safety will also be assessed.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 452 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
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Inclusion Criteria:
Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion.
Drug: Paliperidone palmitate (R092670)
Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
Drug: Risperidone
Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion.
Risperidone LAI intramuscular at a dose of 25 mg on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal
The PANSS 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 rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening.
Time frame: Baseline, Day 92 or early withdrawal
Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal
This PSP assesses the degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 4, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; \<= 30, functioning so poorly as to require intensive supervision.
Time frame: Baseline, Day 92 or early withdrawal
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher change scores indicate worsening.
Time frame: Baseline, Day 92 or early withdrawal
Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal
The self-administered sleep VAS scale (0-100 millimeter \[mm\]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).
Time frame: Baseline, Day 92 or early withdrawal
Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal
A responder is defined as a participant who improved from baseline in the PANSS total score by 30 percent or more.
Time frame: Day 92 or early withdrawal
| Milestone | Paliperidone Palmitate | Risperidone Long Acting Injection (LAI) |
|---|---|---|
| Started | 229 | 223 |
| Completed | 165 | 185 |
| Not completed | 64 | 38 |
| Withdrew: Lack of efficacy | 22 | 9 |
| Withdrew: Lost to follow-up | 9 | 14 |
| Withdrew: Pregnancy | 2 | 0 |
| Withdrew: Protocol violation | 3 | 1 |
| Withdrew: Withdrawal by subject | 16 | 5 |
| Withdrew: Adverse event | 4 | 5 |
| Withdrew: Other | 8 | 4 |
The PANSS 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 rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening.
| Units on scale | Paliperidone Palmitate | Risperidone Long Acting Injection (LAI) |
|---|---|---|
| Baseline | 82.1 ± 11.95 | 84.4 ± 12.69 |
| Change at Day 92 or Early Withdrawal | -23.6 ± 16.28 | -26.9 ± 15.43 |
This PSP assesses the degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 4, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; \<= 30, functioning so poorly as to require intensive supervision.
| Units on scale | Paliperidone Palmitate | Risperidone Long Acting Injection (LAI) |
|---|---|---|
| Baseline | 47.8 ± 12.42 | 45.3 ± 11.29 |
| Change at Day 92 or Early Withdrawal | 16.8 ± 14.76 | 18.6 ± 13.92 |
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher change scores indicate worsening.
| Units on scale | Paliperidone Palmitate | Risperidone Long Acting Injection (LAI) |
|---|---|---|
| Baseline | 4.9 ± 0.82 | 5.0 ± 0.81 |
| Change at Day 92 or Early Withdrawal | -1.5 ± 1.24 | -1.7 ± 1.16 |
The self-administered sleep VAS scale (0-100 millimeter \[mm\]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).
| millimeter (mm) | Paliperidone Palmitate | Risperidone Long Acting Injection (LAI) |
|---|---|---|
| QoS, Baseline | 64.1 ± 25.40 | 66.6 ± 24.22 |
| QoS, Change at Day 92 or Early Withdrawal | 8.2 ± 26.95 | 10.0 ± 26.18 |
| DD, Baseline | 29.9 ± 25.25 | 29.6 ± 23.50 |
| DD, Change at Day 92 or Early Withdrawal | -4.1 ± 27.26 | -4.9 ± 24.12 |
A responder is defined as a participant who improved from baseline in the PANSS total score by 30 percent or more.
| Percentage of participants | Paliperidone Palmitate | Risperidone Long Acting Injection (LAI) |
|---|---|---|
| Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal | 70.7 ± 25.40 | 78.4 ± 24.22 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paliperidone Palmitate | — | 3/229 (1.3%) | 115/229 (50.2%) |
| Risperidone Long Acting Injection (LAI) | — | 8/223 (3.6%) | 127/223 (57%) |
| Event | Paliperidone Palmitate | Risperidone Long Acting Injection (LAI) |
|---|---|---|
| NauseaGastrointestinal disorders | 0/229 | 1/223 |
| VomitingGastrointestinal disorders | 0/229 | 1/223 |
| Lumbar vertebral fractureInjury, poisoning and procedural complications | 0/229 | 1/223 |
| OverdoseInjury, poisoning and procedural complications | 0/229 | 1/223 |
| Road traffic accidentInjury, poisoning and procedural complications | 0/229 | 1/223 |
| ConvulsionNervous system disorders | 0/229 | 1/223 |
| Completed suicidePsychiatric disorders | 0/229 | 1/223 |
| HydronephrosisRenal and urinary disorders | 0/229 | 1/223 |
| NephrolithiasisRenal and urinary disorders | 0/229 | 1/223 |
| Refusal of treatment by patientSocial circumstances | 0/229 | 1/223 |
| Event | Paliperidone Palmitate | Risperidone Long Acting Injection (LAI) |
|---|---|---|
| AkathisiaNervous system disorders | 30/229 | 44/223 |
| TremorNervous system disorders | 24/229 | 40/223 |
| InsomniaPsychiatric disorders | 41/229 | 30/223 |
| RestlessnessPsychiatric disorders | 16/229 | 22/223 |
| Upper respiratory tract infectionInfections and infestations | 18/229 | 13/223 |
| ConstipationGastrointestinal disorders | 17/229 | 12/223 |
| Blood prolactin increasedInvestigations | 17/229 | 12/223 |
| Musculoskeletal stiffnessMusculoskeletal and connective tissue disorders | 10/229 | 16/223 |
| BradykinesiaNervous system disorders | 16/229 | 9/223 |
| AnxietyPsychiatric disorders | 10/229 | 13/223 |
| Age Continuous(years) | Paliperidone Palmitate | Risperidone Long Acting Injection (LAI) | Total |
|---|---|---|---|
| Mean | 32 ± 10.75 | 31.5 ± 11.03 | 31.7 ± 10.88 |
| Sex: Female, Male(Participants) | Paliperidone Palmitate | Risperidone Long Acting Injection (LAI) | Total |
|---|---|---|---|
| Female | 142 | 129 | 271 |
| Male | 87 | 94 | 181 |
| Age Categorical(Participants) | Paliperidone Palmitate | Risperidone Long Acting Injection (LAI) | Total |
|---|---|---|---|
| 18-25 Years | 87 | 92 | 179 |
| 26-50 Years | 125 | 114 | 239 |
| 51-65 Years | 17 | 17 | 34 |
| >65 Years | 0 | 0 | 0 |
| <18 Years | 0 | 0 | 0 |
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Xian-Janssen Pharmaceutical Ltd.