Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate
The purpose of this study is to explore the efficacy of paliperidone palmitate administered as a once monthly injection in patients with an acute exacerbation of schizophrenia.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Patients With Recently Exacerbated Schizophrenia With Paliperidone Palmitate - A Pilot Study|
- Change in the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline to 4 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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..
|Study Start Date:||September 2011|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|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.
This is an open-label (patients and study staff will know the identity of treatments assigned) study of paliperidone palmitate in patients with acute an exacerbation of schizophrenia. The total duration of the study will be approximately 4 months. Eligible patients without a documented history of exposure to oral risperidone or paliperidone extended-release (ER), or intramuscular (IM) RISPERDAL CONSTA or paliperidone palmitate will receive oral risperidone 1 mg/day or extended release (ER) OROS paliperidone 3 mg/day for at least 3 days before the first injection of the study drug (paliperidone palmitate) for tolerability testing. Paliperidone palmitate will be administered to patients as an intramuscular (IM) injection in the deltoid (upper arm) or gluteal (buttocks) muscle.
Please refer to this study by its ClinicalTrials.gov identifier: 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.|