A Study of Effectiveness and Safety of Paliperidone Extended-release (ER) Tablets in the Prevention of Recurrence in Adult Patients With Schizophrenia.
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Evaluating Paliperidone Extended Release Tablets in the Prevention of Recurrence in Subjects With Schizophrenia
1 other identifier
interventional
111
0 countries
N/A
Brief Summary
The purpose of this study is to determine the efficacy (effectiveness) and safety of paliperidone ER compared with placebo in the prevention of recurrence of symptoms of schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
Started Mar 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
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 30, 2004
CompletedFirst Posted
Study publicly available on registry
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedJune 8, 2011
April 1, 2010
June 30, 2004
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to recurrence, defined as the time between randomization to treatment in the double-blind period and the first documentation of a recurrence.
Secondary Outcomes (1)
Change in PANSS total and subscale scores from randomization to each visit and to the end of the study. Change from baseline in CGI-S at each assessment time point and at endpoint. Incidence of adverse events throughout study.
Interventions
Eligibility Criteria
You may qualify if:
- DSM-IV diagnosis of schizophrenia at least 1 year before screening
- experiencing an acute schizophrenic episode with a total PANSS score between 70 and 120
- agree to be hospitalized for a minimum of 14 days at the start of the study
- capable of administering study medication themselves or have assistance with study medication administration consistently available throughout the study
- resided at the same address continuously for at least 30 days prior to screening
- able and willing to fill out self administered questionnaires
- washout of antiparkinsonian medications, beta-blockers
- antiepileptics, lithium 3 days prior to the start of the run-in phase
You may not qualify if:
- DSM-IV Axis I diagnosis other than schizophrenia
- preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
- injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
- previous history of lack of response to risperidone when acutely psychotic
- history of neuroleptic malignant syndrome
- significant risk of suicidal or violent behavior
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Mathews M, Gopal S, Singh A, Nuamah I, Pungor K, Tan W, Soares B, Kim E, Savitz AJ. Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies. Neuropsychiatr Dis Treat. 2020 Jun 19;16:1533-1542. doi: 10.2147/NDT.S221242. eCollection 2020.
PMID: 32606705DERIVEDWeiden PJ, Kim E, Bermak J, Turkoz I, Gopal S, Berwaerts J. Does Half-Life Matter After Antipsychotic Discontinuation? A Relapse Comparison in Schizophrenia With 3 Different Formulations of Paliperidone. J Clin Psychiatry. 2017 Jul;78(7):e813-e820. doi: 10.4088/JCP.16m11308.
PMID: 28640988DERIVEDKramer M, Simpson G, Maciulis V, Kushner S, Vijapurkar U, Lim P, Eerdekens M. Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol. 2007 Feb;27(1):6-14. doi: 10.1097/JCP.0b013e31802dda4a.
PMID: 17224706DERIVED
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
June 30, 2004
First Posted
July 1, 2004
Study Start
March 1, 2004
Study Completion
August 1, 2005
Last Updated
June 8, 2011
Record last verified: 2010-04