Status:
COMPLETED
A Phase 4 Study to Evaluate Response to Treatment and Safety of Paliperidone Extended-Release in Participants With Schizophrenia
Lead Sponsor:
Janssen-Cilag Turkey
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ...
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 parti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00915512
Start Date
May 1 2009
End Date
October 1 2011
Last Update
October 10 2013
Active Locations (7)
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1
Adana, Turkey (Türkiye)
2
Ankara, Turkey (Türkiye)
3
Antalya, Turkey (Türkiye)
4
Bursa, Turkey (Türkiye)