Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate
|ClinicalTrials.gov Identifier: NCT01448720|
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : September 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Paliperidone palmitate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate - A Pilot Study|
|Study Start Date :||September 2011|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
|Experimental: Paliperidone palmitate||
Drug: Paliperidone palmitate
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.
- Change in the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline to 4 months ]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).
- Change from Baseline in global severity of illness using the clinical global impression - severity (CGI-S) scores [ Time Frame: Baseline to 4 months ]The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, the patient will be assessed on severity of mental illness at the time of rating between 1 (not ill) and 7 (extremely severe).
- Change from Baseline in the personal and social performance scale (PSP) [ Time Frame: Baseline to 4 months ]The PSP scale assesses the degree of dysfunction a patient exhibits over a 7-day period within 4 domains of behavior:(a) socially useful activities, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behavior. A score between 71 and 100 indicates only mild difficulties, and one between 31 and 70 indicates varying degrees of disability. A patient with a score of 30 or less has functioning so poor he or she requires intensive support or supervision..
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448720
|Porto Alegre, Brazil|
|Riberao Preto, Brazil|
|Sao Jose, Brazil|
|Sao Paulo, Brazil|
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|