A Phase 4 Study to Evaluate Response to Treatment and Safety of Paliperidone Extended-Release in Participants With Schizophrenia
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
2 other identifiers
interventional
84
1 country
7
Brief Summary
The purpose of this study is to evaluate the response to treatment and safety of paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 schizophrenia
Started May 2009
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 5, 2009
CompletedFirst Posted
Study publicly available on registry
June 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedOctober 10, 2013
October 1, 2013
2.4 years
June 5, 2009
October 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Total Personal and Social Performance (PSP) Score at 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.
Baseline and Month 12
Secondary Outcomes (4)
Change from Baseline in Global Assessment of Functioning (GAF) Score at Month 12
Baseline and Month 12
Change from Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score and Subscales Score at Month 12
Baseline and Month 12
Change from Baseline in Short Form (SF)-36 Scale Score at Month 12
Baseline and Month 12
Change from Baseline in Percentage of Participants With Relapse at Month 12
Baseline and Month 12
Study Arms (1)
Paliperidone extended-release (ER)
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Schizophrenia diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Recent onset (less than 3 years after the first episode/hospitalization) schizophrenia but either not on antipsychotic medication for at least 3 months or in need of antipsychotic medication switches because of safety and/or lack of efficacy reasons
- To be considered physically healthy at Screening according to vital signs and physical examination findings. If there are abnormalities, they must be consistent with the underlying illness in the study population
- Women at postmenopausal state for at least 1 year; or undergone surgical sterilization, or for women with child-bearing status, should be willing to use an effective contraceptive method throughout the study
- Participants who are willing and capable to complete the questionnaires
You may not qualify if:
- Use of clozapine, depot neuroleptics or risperidone within the last 3 months
- Any unstable clinical condition including clinically important abnormal laboratory findings
- Previous and current tardive dyskinesia (abnormal involuntary movements which primarily affect the extremities, trunk, or jaw) symptoms
- History of malignant neuroleptic syndrome
- To be considered carrying high risk regarding adverse effects, homicide and/or suicide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Adana, Turkey (Türkiye)
Unknown Facility
Ankara, Turkey (Türkiye)
Unknown Facility
Antalya, Turkey (Türkiye)
Unknown Facility
Bursa, Turkey (Türkiye)
Unknown Facility
Istanbul, Turkey (Türkiye)
Unknown Facility
Manisa, Turkey (Türkiye)
Unknown Facility
Samsun, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag Turkey Clinical Trial
Janssen-Cilag Turkey
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2009
First Posted
June 8, 2009
Study Start
May 1, 2009
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
October 10, 2013
Record last verified: 2013-10