A Phase 4 Study to Evaluate Response to Treatment and Safety of Paliperidone Extended-Release in Participants With Schizophrenia
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|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.
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): NCT00915512
|Study Director:||Janssen-Cilag Turkey Clinical Trial||Janssen-Cilag Turkey|