A Study of the Effectiveness and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia
The Efficacy And Safety Of Risperidone In The Treatment Of Adolescents With Schizophrenia: A Six-Month Open-Label Study.
1 other identifier
interventional
381
0 countries
N/A
Brief Summary
The purpose of the study is to assess the safety and effectiveness of risperidone (an antipsychotic medication) in adolescents with schizophrenia over 6 months of treatment.
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 Apr 2001
Longer than P75 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
April 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 28, 2005
CompletedFirst Posted
Study publicly available on registry
October 31, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedJune 8, 2011
March 1, 2010
October 28, 2005
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Positive and Negative Syndrome Scale for Schizophrenia (PANSS) score from baseline to each visit during treatment; incidence of adverse events throughout study
Secondary Outcomes (1)
Clinical Global Impression-Severity of Illness (CGI-Severity) and Clinical Global Impression-Improvement (CGI-Improvement) at each visit; Children's Global Assessment Scale at start and end of study; clinical laboratory tests, vital signs, weight, ECGs.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of schizophrenia by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
- expected to benefit from continuous treatment with risperidone, including patients who cannot tolerate their current antipsychotic therapy or are still exhibiting symptoms
- Positive and Negative Syndrome Scale for Schizophrenia (PANSS) score between 40 and 120 at start of study (not required for patients continuing from the 2 previous studies)
You may not qualify if:
- Meet criteria for other psychiatric disorders or mental retardation (documented IQ \<70)
- history of substance dependence (including alcohol, but excluding nicotine and caffeine)
- hypersensitivity or intolerance to risperidone
- extrapyramidal symptoms (EPS) such as tremor that are not adequately controlled with medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Pandina G, Kushner S, Karcher K, Haas M. An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia. Child Adolesc Psychiatry Ment Health. 2012 Jun 7;6(1):23. doi: 10.1186/1753-2000-6-23.
PMID: 22676070DERIVED
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
October 28, 2005
First Posted
October 31, 2005
Study Start
April 1, 2001
Study Completion
December 1, 2006
Last Updated
June 8, 2011
Record last verified: 2010-03