The Efficacy and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia
1 other identifier
interventional
279
0 countries
N/A
Brief Summary
A clinical study to compare the safety and effectiveness of two different dose ranges of risperidone solution in the treatment of adolescents with a diagnosis of 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 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
May 2, 2002
CompletedFirst Posted
Study publicly available on registry
May 3, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedJune 8, 2011
March 1, 2010
May 2, 2002
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint
Secondary Outcomes (1)
Change from baseline in PANSS subscale scores and Clinical Global Impression (CGI-S and CGI-I) scores, number of subjects achieving a clinical response (at least 20% improvement in total PANSS), safety, tolerability and pharmacokinetics.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects will be eligible for study enrollment if they: are adolescents between the ages of 13 and 17 years
- have a confirmed diagnosis of schizophrenia and are suffering from an acute episode
- provide their assent and parental informed consent to participate
- are otherwise relatively healthy on the basis of a medical and physical examination
- and are able to be in-patients for approximately 2 weeks.
You may not qualify if:
- Subjects will be excluded from the study if they: meet the criteria for psychiatric disorders other than schizophrenia
- have moderate or severe mental retardation
- fail to respond to treatment with at least two typical or atypical antipsychotics
- have a history of substance dependence within the 3 months before screening
- are considered at risk for suicidal or violent behavior
- have a seizure disorder
- have a history of neuroleptic malignant syndrome, similar encephalopathic syndrome, or tardive dyskinesia
- or receive prohibited medication within a specified period before screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Haas M, Eerdekens M, Kushner S, Singer J, Augustyns I, Quiroz J, Pandina G, Kusumakar V. Efficacy, safety and tolerability of two dosing regimens in adolescent schizophrenia: double-blind study. Br J Psychiatry. 2009 Feb;194(2):158-64. doi: 10.1192/bjp.bp.107.046177.
PMID: 19182179DERIVED
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
May 2, 2002
First Posted
May 3, 2002
Study Start
April 1, 2001
Study Completion
March 1, 2006
Last Updated
June 8, 2011
Record last verified: 2010-03