A Study of the Effectiveness and Safety of Risperidone in the Treatment of Behavioral Disturbances in Patients With Dementia
Risperidone in the Treatment of Behavioral Disturbances in Demented Patients: an International, Multicenter, Placebo-controlled, Double-blind, Parallel-group Trial Using Haloperidol as Internal Reference
1 other identifier
interventional
349
0 countries
N/A
Brief Summary
The purpose of the study is to compare the safety and efficacy of risperidone (an antipsychotic medication) to that of 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 P50-P75 for phase_3
Started Apr 1995
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, 1995
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 1996
CompletedFirst Submitted
Initial submission to the registry
November 4, 2005
CompletedFirst Posted
Study publicly available on registry
November 7, 2005
CompletedJanuary 14, 2011
January 1, 2011
November 4, 2005
January 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to end of double-blind treatment on the total BEHAVE-AD score.
Secondary Outcomes (1)
Change from baseline to end of double-blind treatment in global rating, total BEHAVE-AD score, total CMAI score, CGI severity, FAST, and MMSE; safety evaluations conducted throughout the study
Interventions
Eligibility Criteria
You may qualify if:
- Patients with dementia of the Alzheimer's type, mixed dementia, or vascular dementia, (as classified by the Diagnostic and Statistical Manual of Mental Diseases, 4th edition \[DSM-IV\]) and have behavioral disturbances
- a score \>=4 on the FAST
- a score \<=23 on the MMSE
- a BEHAVE-AD total score \>=8, and a BEHAVE-AD global rating \>=1
- must be institutionalized.
You may not qualify if:
- Patients with other medical or neurological conditions in which cognition (thinking, perception, learning, verbal communication, memory, judgment) is diminished (for example, drug overdosage, severe liver, heart, lung, and kidney malfunctions, Parkinson's disease)
- other psychiatric disorders, including major depression, schizophrenia, substance abuse or dependence
- abnormal electrocardiogram (ECG) findings
- abnormal clinical laboratory test findings.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
De Deyn PP, Rabheru K, Rasmussen A, Bocksberger JP, Dautzenberg PL, Eriksson S, Lawlor BA. A randomized trial of risperidone, placebo, and haloperidol for behavioral symptoms of dementia. Neurology. 1999 Sep 22;53(5):946-55. doi: 10.1212/wnl.53.5.946.
PMID: 10496251RESULTRoughley M, Mena C, Howard R, Reeves S, Bertrand J. Guiding safer risperidone prescribing in Alzheimer's disease with therapeutic drug monitoring. Br J Clin Pharmacol. 2023 Jul;89(7):2316-2321. doi: 10.1111/bcp.15692. Epub 2023 Feb 28.
PMID: 36791792DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutica N.V. Clinical Trial
Janssen Pharmaceutica N.V.
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 4, 2005
First Posted
November 7, 2005
Study Start
April 1, 1995
Study Completion
December 1, 1996
Last Updated
January 14, 2011
Record last verified: 2011-01