Trial Evaluating the Efficacy and Safety of 2 Fixed Doses of Paliperidone Extended-Release (ER) Tablets in the Treatment of Adult Patients With Schizophrenia
A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Dose-response Study to Evaluate the Efficacy and Safety of 2 Fixed Dosages of Paliperidone Extended Release Tablets and Olanzapine, With Open-label Extension, in the Treatment of Patients With Schizophrenia
1 other identifier
interventional
12
0 countries
N/A
Brief Summary
The purpose of this trial is to determine if paliperidone ER is an effective treatment for adults with schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 schizophrenia
Started Jan 2004
Shorter than P25 for phase_3 schizophrenia
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
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 11, 2004
CompletedFirst Posted
Study publicly available on registry
February 16, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedJune 8, 2011
April 1, 2010
February 11, 2004
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in total PANSS score to the end of the double-blind phase.
Secondary Outcomes (1)
Changes from baseline to the end of the double-blind phase in PSP, CGI-S, and SQLS-R4.
Interventions
Eligibility Criteria
You may qualify if:
- 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. Open-label phase: must have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy.
You may not qualify if:
- DSM-IV axis I diagnosis other than schizophrenia
- history of neuroleptic malignant syndrome (NMS)
- history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
- previous history of lack of response to risperidone when acutely psychotic
- significant risk of suicidal or violent behavior.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Janicak PG, Wu JH, Mao L. Hospitalization rates before and after initiation of paliperidone ER in patients with schizophrenia: results from open-label extensions of the US double-blind trials. Curr Med Res Opin. 2008 Jun;24(6):1807-15. doi: 10.1185/03007990802119368.
PMID: 18559166DERIVEDMeltzer HY, Bobo WV, Nuamah IF, Lane R, Hough D, Kramer M, Eerdekens M. Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 6-week, placebo-controlled studies. J Clin Psychiatry. 2008 May;69(5):817-29. doi: 10.4088/jcp.v69n0515.
PMID: 18466043DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 11, 2004
First Posted
February 16, 2004
Study Start
January 1, 2004
Study Completion
January 1, 2005
Last Updated
June 8, 2011
Record last verified: 2010-04