Safety Study With Paliperidone ER Extended-Release (ER) Tablets in Geriatric Patients With Schizophrenia
A Randomized, 6-Week Double-Blind, Placebo-Controlled Study With an Optional 24-Week Open-Label Extension to Evaluate the Safety and Tolerability of Flexible Doses of Paliperidone Extended Release in the Treatment of Geriatric Patients With Schizophrenia
1 other identifier
interventional
114
0 countries
N/A
Brief Summary
The primary objective of the study is to evaluate the safety and tolerability of flexible dosages of paliperidone ER as compared with placebo in patients with schizophrenia who are 65 years of age or older. The primary objective of the open-label extension is the long-term assessment of safety and tolerability of paliperidone ER in patients diagnosed with 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 Aug 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
First Submitted
Initial submission to the registry
June 14, 2004
CompletedFirst Posted
Study publicly available on registry
June 16, 2004
CompletedStudy Start
First participant enrolled
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedJune 8, 2011
November 1, 2010
June 14, 2004
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dosages and duration of treatment; incidence of adverse events throughout study. Changes from baseline to end of study in laboratory values, vital signs, electrocardiograms, and AIMS, BARS, and SAS scale scores.
Secondary Outcomes (1)
The change from baseline score to end point score at each point of measurement for PANSS, PSP, CGI S, SQLS-R4, and Sleep VAS.
Interventions
Eligibility Criteria
You may qualify if:
- Double-Blind Phase: 65 years of age or older
- DSM-IV diagnosis of schizophrenia for at least 1 year
- total PANSS score at screening and baseline between 70 and 120, inclusive
- agrees to hospitalization for a minimum of 14 days and for the duration of the study, if clinically indicated
- Open-label treatment phase: completed 6 weeks of the double-blind treatment phase or finished at least 21 days of treatment and discontinued because of lack of efficacy.
You may not qualify if:
- DSM-IV Axis I diagnosis other than schizophrenia
- history of tardive dyskinesia or neuroleptic malignant syndrome (NMS)
- history of any severe preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
- previous history of a lack of response (2 adequate trials) to any antipsychotic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Tzimos A, Samokhvalov V, Kramer M, Ford L, Gassmann-Mayer C, Lim P, Eerdekens M. Safety and tolerability of oral paliperidone extended-release tablets in elderly patients with schizophrenia: a double-blind, placebo-controlled study with six-month open-label extension. Am J Geriatr Psychiatry. 2008 Jan;16(1):31-43. doi: 10.1097/JGP.0b013e31815a3e7a.
PMID: 18165460RESULT
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 14, 2004
First Posted
June 16, 2004
Study Start
August 1, 2004
Study Completion
May 1, 2005
Last Updated
June 8, 2011
Record last verified: 2010-11