A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Behavioral Disturbances in Patients With Dementia
A Randomized, Double-Blind, Placebo-Controlled Study of Risperidone for Treatment of Behavioral Disturbances in Subjects With Dementia
1 other identifier
interventional
626
0 countries
N/A
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of risperidone (an antipsychotic medication) versus placebo in the treatment of behavioral disturbances associated with dementia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
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 Completion
Last participant's last visit for all outcomes
March 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 10, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedDecember 3, 2010
December 1, 2010
November 10, 2005
December 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of >= 30% from baseline to the end of double-blind treatment on the total BEHAVE-AD score.
Secondary Outcomes (1)
Change from baseline to the end of double-blind treatment in BEHAVE-AD global rating and total score; total CMAI score; CGI and CGI change from baseline; PSMS; safety evaluations conducted throughout the study.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with a diagnosis of dementia of the Alzheimer's type, mixed dementia, or vascular dementia, as classified by the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
- a score of 4 or more on the Functional Assessment Staging (FAST), a diagnostic tool for determining the stage of dementia
- a score of 23 or lower on the Mini-Mental State Examination (MMSE), a clinical measure used to evaluate cognition
- a BEHAVE-AD total score of at least 8, and a BEHAVE-AD global rating of at least 1
- residence in a psychiatric hospital, nursing home, or other long-term care facility for at least 1 month.
You may not qualify if:
- Patients with untreated, reversible causes of dementia
- with general medical or neurological conditions in which cognition is diminished (for example, untreated vitamin deficiency, severe liver or kidney malfunctions, brain tumor, etc.)
- with dementia related to HIV infection (human immunodeficiency virus)
- with a substance-induced persisting dementia
- with psychiatric disorders that could account for the behavior disturbances, such as schizophrenia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen, LPlead
Related Publications (1)
Katz IR, Jeste DV, Mintzer JE, Clyde C, Napolitano J, Brecher M. Comparison of risperidone and placebo for psychosis and behavioral disturbances associated with dementia: a randomized, double-blind trial. Risperidone Study Group. J Clin Psychiatry. 1999 Feb;60(2):107-15. doi: 10.4088/jcp.v60n0207.
PMID: 10084637RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen, LP Clinical Trial
Janssen, LP
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
November 10, 2005
First Posted
November 15, 2005
Study Completion
March 1, 1997
Last Updated
December 3, 2010
Record last verified: 2010-12