Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00589914|
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : October 4, 2011
Last Update Posted : June 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: RISPERDAL CONSTA Drug: Paliperidone palmitate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1221 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular Injection in Subjects With Schizophrenia|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Active Comparator: RISPERDAL CONSTA
RISPERDAL CONSTA 25-50 mg eq every 2 weeks
Drug: RISPERDAL CONSTA
RISPERDAL CONSTA: Type=exact number, unit=mg, number=25, 37.5, or 50, form=suspension for injection, route=Intramuscular use. One i.m. injection of RISPERDAL CONSTA 25-50 mg eq every 2 weeks at V4, V6, V7, V8, V9, and V10. PALIPERIDONE PALMITATE PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 2 weeks at Baseline and at V4, V7, and V9. RISPERIDONE: Type=up to, unit=mg, number=1 to 6, form=Tablet, route=Oral Use. One tablet for the first 4 weeks (28 days) of the DB treatment period.
Paliperidone Palmitate 50-150 mg eq every 4 wks
Drug: Paliperidone palmitate
PALIPERIDONE PALMITATE: Type=exact number, unit=mg, number=50, 100, or 150, form=suspension for injection, route=Intramuscular use. One i.m. injection of Paliperidone palmitate 50-150 mg eq every 4 wks at Baseline, V4, V7, and V9. RISPERDAL CONSTA PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 4 weeks at Baseline, V4, V7, and V9.
- Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia [ Time Frame: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks) ]The PANSS scale is used to assess the neuropsychiatric symptoms of schizophrenia. The 30-item PANSS scale 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 item rated on a scale of 1 (absent) to 7 (extreme).
- The Change From Baseline for the CGI-S Score [ Time Frame: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)] ]The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the patient's condition at a given time. A qualified rater administered the CGI-S.
- The Change From Baseline in the PSP Score [ Time Frame: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks) ]The PSP scale is used to assess the degree of dysfunction a patient exhibits over a 7-day period within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numeric score. A score between 71 and 100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction, and a patient with a score of 30 or less has functioning so poor he or she requires intensive supervision.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00589914
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|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|