A Phase 4 Study to Evaluate Response to Treatment and Safety of Paliperidone Extended-Release in Participants With Schizophrenia
|ClinicalTrials.gov Identifier: NCT00915512|
Recruitment Status : Completed
First Posted : June 8, 2009
Last Update Posted : October 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Paliperidone extended-release (ER)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single-arm, Multicenter, Phase IV Study to Evaluate the Response to Treatment and Safety of Flexible Dose Treatment With Extended-release Paliperidone in Patients With Schizophrenia|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
|Experimental: Paliperidone extended-release (ER)||
Drug: Paliperidone extended-release (ER)
Paliperidone ER tablets will be administered orally once daily as flexible dose ranging from 3 to 12 milligram (mg) per day for 12 months. The recommended dose will be 6 mg once daily.
Other Name: Invega
- Change from Baseline in Total Personal and Social Performance (PSP) Score at Month 12 [ Time Frame: Baseline and Month 12 ]The PSP is a clinician-rated scale that reflects social functioning in 4 domains of behavior (socially useful activities including work and study, personal and social relationships, self care, and disturbing and aggressive behaviors). The total score ranges from 1 to 100 (score of 71 to 100 will have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision) divided into 10 equal intervals to rate the degree of difficulty (i=absent to vi=very severe) in each of the 4 domains.
- Change from Baseline in Global Assessment of Functioning (GAF) Score at Month 12 [ Time Frame: Baseline and Month 12 ]The GAF is a 100-point tool to measure overall psychological, social and occupational functioning of adults. The higher score range (that is, 91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (that is, 1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.
- Change from Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score and Subscales Score at Month 12 [ Time Frame: Baseline and Month 12 ]The PANSS is a scale which measures the severity of psychotic symptoms of schizophrenia. Score ranges from 30 to 210 where 30=best and 210=worst. The scale consists of three subscales: positive subscale (Range 7 to 49), negative subscale (Range 7 to 49) and general psychopathology subscale (Range 16 to 112), which measures from absent to extreme condition. Higher scores indicate worsening.
- Change from Baseline in Short Form (SF)-36 Scale Score at Month 12 [ Time Frame: Baseline and Month 12 ]The SF-36 is a survey that measures 8 domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Each item is scored on a range of 0 to 100. Worst value is 0 and best value is 100.
- Change from Baseline in Percentage of Participants With Relapse at Month 12 [ Time Frame: Baseline and Month 12 ]The relapse will be diagnosed if participants meet any of the following criteria on 2 consecutive evaluations conducted 3 to 5 days apart: Psychiatric hospitalization; increase in level of care necessary and 25 percent increase in total PANSS score from Baseline; significant clinical deterioration defined as a clinical global impression of change scale score of 6 (indicating much worse); deliberate self-injury; clinically significant suicidal or homicidal ideation; violent behavior resulting in significant injury to another person or property; exceeding the registered dose of drug.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915512
|Study Director:||Janssen-Cilag Turkey Clinical Trial||Janssen-Cilag Turkey|