A 52 Week Open-label Extension Trial Following the Double-blind Efficacy and Safety Study R076477-SCH-305.
Open Label Extension to R076477-SCH-305 to Evaluate the Safety and Tolerability of Paliperidone ER in Subjects With Schizophrenia.
1 other identifier
interventional
407
0 countries
N/A
Brief Summary
Open-Label Extension to the double-blind effectiveness and safety study R076477-SCH-305 to evaluate long-term safety and tolerability in patients with schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started Feb 2004
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
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 24, 2008
CompletedFirst Posted
Study publicly available on registry
April 29, 2008
CompletedJune 8, 2011
March 1, 2010
April 24, 2008
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Flexibly-dosed ER OROS paliperidone 3 mg to 15 mg/day was safe and well tolerated in patients with schizophrenia. The safety profile was generally consistent with that observed in subjects after short-term use in the double-blind studies
Secondary Outcomes (1)
Findings showed stability of symptoms or further improvements in the severity of symptoms associated with schizophrenia (PANSS), personal and social functioning (PSP), global severity of illness (CGI-S), and patient-rated symptoms and well-being (SQLS)
Interventions
Eligibility Criteria
You may qualify if:
- Study R076477-SCH-707 enrolled patients who met the DSM-IV criteria of schizophrenia for at least 1 year
- Eligible patients were experiencing active symptoms at the time of enrollment and had a PANSS total score between 70 and 120
- The open-label extension study population comprised patients who had completed the 6-week double-blind phase of the study or who had discontinued due to lack of efficacy after at least 21 days of treatment.
You may not qualify if:
- Not eligible to enter the open-label phase if believed to be at significant risk for suicidal or violent behavior during the open-label extension trial
- Were pregnant
- Or had received an injection of a depot antipsychotic since entry into the preceding double-blind phase
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Kozma C, Dirani R, Canuso C, Mao L. Change in employment status over 52 weeks in patients with schizophrenia: an observational study. Curr Med Res Opin. 2011 Feb;27(2):327-33. doi: 10.1185/03007995.2010.541431. Epub 2010 Dec 15.
PMID: 21155708DERIVED
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 24, 2008
First Posted
April 29, 2008
Study Start
February 1, 2004
Study Completion
June 1, 2006
Last Updated
June 8, 2011
Record last verified: 2010-03