Clinical trial NCT00915512: A Phase 4 Study to Evaluate Response to Treatment and Safety of Paliperidone Extended-Release in Participants With Schizophrenia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone
Invega
Lead sponsor: Janssen-Cilag Turkey
Sponsor class: INDUSTRY
First posted: 2009-06-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: This is a non-randomized, single-arm, multi-center (conducted in more than one center) study to explore response to treatment and safety of flexible dose of paliperidone extended-release (ER) in participants with schizophrenia. During the study period, dose of paliperidone ER will remain within the range of 3 to 12 milligram per day and will be administered for 12 months. Both hospitalized and non-hospitalized participants may be included in the study. Participants may switch to any effective dose of paliperidone ER from any oral antipsychotic medication without dose adjustment or if required, cross-dose adjustment may be done. Maximum 4 weeks of switching period is allowed. Use of anticholinergic (opposing the actions of the acetylcholine, a neurotransmitter) drugs will not be restricted. Response to treatment will be evaluated primarily through total Personal and Social Performance (PSP) Scale. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline in Total Personal and Social Performance (PSP) Score at Month 12
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Change from Baseline in Global Assessment of Functioning (GAF) Score at Month 12
timeFrame: Baseline and Month 12
measure: Change from Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score and Subscales Score at Month 12
timeFrame: Baseline and Month 12
measure: Change from Baseline in Short Form (SF)-36 Scale Score at Month 12
timeFrame: Baseline and Month 12
measure: Change from Baseline in Percentage of Participants With Relapse at Month 12
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Adana
country: Turkey
city: Ankara
country: Turkey
city: Antalya
country: Turkey
city: Bursa
country: Turkey
city: Istanbul
country: Turkey
city: Manisa
country: Turkey
city: Samsun
country: Turkey
Study officials:
affiliation: Janssen-Cilag Turkey
name: Janssen-Cilag Turkey Clinical Trial
role: STUDY_DIRECTOR
References: