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A Study of the Effectiveness and Safety of Risperidone in the Treatment of Behavioral Disturbances in Patients With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00249158
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : November 19, 2010
Information provided by:
Janssen-Cilag Pty Ltd

Brief Summary:
The purpose of the study is to compare the effectiveness of an oral formulation of risperidone (an antipsychotic medication) to that of placebo for treating behavioral and psychological signs and symptoms in dementia (BPSSD), specifically aggression, delusions, and hallucinations, in patients with dementia.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Vascular Dementia Drug: Risperidone Phase 3

Detailed Description:
Dementia is a term used for a collection of symptoms that can be caused by a number of diseases or injuries that affect the brain. Individuals with dementia have a loss of function in cognition (thinking, perception, learning, verbal communication, memory, judgment), which may lead to behavioral and personality changes (for example, agitation, delusions, hallucinations). Some causes of dementia are reversible; however, irreversible dementia is caused by certain conditions, such as Alzheimer's disease. Dementia is common in elderly individuals, but it is not a normal part of aging. This is a randomized, double-blind, parallel-group, placebo-controlled study comparing the effectiveness and safety of risperidone to placebo in patients with behavioral disturbances associated with dementia. The study is composed of two periods: a 1-week run-in period in which patients are discontinued from other antipsychotic drugs and take placebo twice daily and a 12-week double-blind period. At the end of the run-in period, patients are randomly assigned to oral solutions of either risperidone or placebo. The starting dose of risperidone is 0.25 mg twice daily and increasing to 0.5 mg twice daily (1 mg/day). If 1 mg/day shows an insufficient response, a maximum of 1 mg twice daily of risperidone is permitted. The patient receives study drugs for the 12-week double-blind period. The primary measure of effectiveness is the change from baseline to the end of double-blind treatment in the Cohen-Mansfield Agitation Inventory (CMAI), a questionnaire evaluating agitation. Additional measures of efficacy include the change from baseline to end of double-blind treatment in the Behavior Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD), a rating scale used to evaluate behavior symptoms in patients with Alzheimer's disease; the Clinical Global Impressions (CGI), a rating system used to evaluate the overall and severity of clinical change in a patient with various diseases affecting the brain; the Functional Assessment Staging (FAST), a diagnosis tool for determining the stage of dementia; and the Mini-Mental State Examination (MMSE), a clinical measure used to evaluate cognition. Safety evaluations include the incidence of adverse events; results of clinical laboratory tests (hematology and biochemistry); measurements of vital signs and body weight; physical examination findings; and the Extrapyramidal Symptoms Rating Scale (ESRS), a scale used to measure effects of antipsychotic medications on motor functions of the patient. The study hypothesis is that risperidone is more effective than placebo, as measured by the total aggression score on the CMAI, in treating behavioral disturbances in demented patients. Risperidone oral solution (1 mg/mL). Starting doses of 0.25 mg twice daily and increasing to 0.5 mg twice daily (1 mg/day). If 1 mg/day shows an insufficient response, a maximum of 1 mg twice daily of risperidone is permitted. Total treatment duration is 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Risperidone in the Treatment of Behavioural and Psychological Signs and Symptoms in Dementia (BPSSD): a Multicentre, Double-blind, Placebo-controlled Parallel-group Trial
Study Start Date : March 1998
Actual Study Completion Date : February 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
Drug Information available for: Risperidone

Primary Outcome Measures :
  1. Change from baseline to the end of double-blind treatment in total aggression score of the CMAI (Cohen-Mansfield Agitation Inventory).

Secondary Outcome Measures :
  1. Change from baseline to end of double-blind treatment in global and total BEHAVE-AD score, BEHAVE-AD cluster scores and in CMAI cluster scores, CGI, and in FAST MMSE; safety evaluations conducted throughout the study.

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Dementia of the Alzheimer's type with behavioral disturbance, vascular dementia with behavioral disturbance, or mixed dementia, as classified by DSM-IV (the Diagnostic and Statistical Manual of Mental Diseases, 4th edition)
  • a score >=4 on the FAST (Functional Assessment Staging, a diagnosis tool for determining the stage of dementia) and a score <=23 on the MMSE (Mini-Mental State Examination, a clinical measure used to evaluate cognition)
  • a BEHAVE-AD (Behavior Pathology in Alzheimer's Disease Rating Scale) total score >=8, and a BEHAVE-AD global rating >=1
  • patient must be living in an nursing home for >=1 month. Exclusion Criteria:
  • Patients with other medical or neurological conditions other than dementia in which cognition is diminished (for example, severe anemia, severe liver, heart, lung, and kidney malfunctions, Parkinson's disease)
  • diagnosis of depression within the 6 months before study entry, schizophrenia, bipolar affective disorder, or schizoaffective disorder
  • history of or moderate to severe tardive dyskinesia, (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs)
  • abnormal clinical laboratory test findings.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00249158

Sponsors and Collaborators
Janssen-Cilag Pty Ltd
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Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd

Publications of Results:
Layout table for additonal information Identifier: NCT00249158     History of Changes
Other Study ID Numbers: CR006010
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010
Keywords provided by Janssen-Cilag Pty Ltd:
Alzheimer's Disease
vascular dementia
mixed dementia
nursing home
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents