Status:
COMPLETED
Evaluation of Effectiveness and Safety of Flexible-dose Paliperidone Extended Release in Patients With Schizoaffective Disorder.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Janssen, LP
Conditions:
Schizoaffective Disorder
Psychotic Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to measure the effectiveness and assess the safety of different dosages (from 3 mg/day to 12 mg/day) of the antipsychotic paliperidone extended-release (ER) in patients wh...
Detailed Description
Schizophrenia and schizoaffective disorder are closely related in terms of symptoms, coexisting conditions, and genetic risk. In previous studies in patients with schizophrenia, treatment with paliper...
Eligibility Criteria
Inclusion
- Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizoaffective disorder
- A total Positive and Negative Symptoms of Schizophrenia (PANSS) score of \>= 60
- A score of \>= 16 on Young Mania Rating Scale (YMRS) or a score of \>= 16 on the Hamilton Depression Rating Scale (HAM-D 21)
Exclusion
- A primary active mental illness diagnosis other than schizoaffective disorder
- Patients with first episode psychosis
- Active substance dependence within previous 6 months
- Treatment with clozapine within 6 months of randomization
- A history of treatment resistance, defined by failure to respond to 2 adequate trials of antipsychotic medication
- Pregnancy, breast-feeding, or planning to become pregnant
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT00412373
Start Date
December 1 2006
End Date
June 1 2008
Last Update
May 9 2014
Active Locations (44)
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1
Cerritos, California, United States
2
Costa Mesa, California, United States
3
Garden Grove, California, United States
4
Huntington Beach, California, United States