Status:
COMPLETED
Trial Evaluating Three Fixed Doses of Paliperidone Extended-Release (ER) Tablets and Olanzapine in the Treatment of Patients With Schizophrenia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of paliperidone ER (3, 9, and 15 mg/day) compared with placebo in adult patients...
Detailed Description
Paliperidone is being developed as a new therapeutic agent for the treatment of schizophrenia. The extended-release (ER) formulation of paliperidone was developed to deliver paliperidone at a relative...
Eligibility Criteria
Inclusion
- Double-blind phase: DSM-IV diagnosis of schizophrenia for at least 1 year
- experiencing an acute episode, with a total PANSS score at screening between 70 and 120
- agree to voluntary hospitalization for a minimum of 14 days
- willing and able to fill out self-administered questionnaires
- must be able to be compliant with self-administration of medication, or have consistent help/support available.
- Open-label phase: have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy
- patient and investigator must agree that open-label treatment is in the best interest of the patient.
Exclusion
- Double-blind phase: DSM-IV axis I diagnosis other than schizophrenia
- DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
- history of tardive dyskinesia or neuroleptic malignant syndrome (NMS)
- history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
- previous history of a lack of response (2 adequate trials) to any antipsychotic
- significant risk of suicidal or violent behavior. Open-label extension: patients believed by the investigator to be at significant risk for suicidal or violent behavior
- received an injection of a depot antipsychotic since entry into the preceding double-blind phase.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
619 Patients enrolled
Trial Details
Trial ID
NCT00083668
Start Date
April 1 2004
End Date
May 1 2005
Last Update
June 8 2011
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