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Sponsored by: |
Janssen-Cilag Pty Ltd |
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Information provided by: | Janssen-Cilag Pty Ltd |
ClinicalTrials.gov Identifier: | NCT00249158 |
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 | Intervention | Phase |
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Alzheimer Disease Vascular Dementia Dementia |
Drug: Risperidone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 218 |
Study Start Date: | February 1998 |
Estimated Study Completion Date: | February 2001 |
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.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR006010 |
Study First Received: | November 4, 2005 |
Last Updated: | April 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00249158 |
Health Authority: | Australia: Department of Health |
mixed dementia Alzheimer's Disease risperidone |
vascular dementia Dementia nursing home |
Arterial Occlusive Diseases Alzheimer Disease Risperidone Vascular Diseases Central Nervous System Diseases Arteriosclerosis Brain Diseases Neurodegenerative Diseases Intracranial Arterial Diseases Cerebrovascular Disorders |
Serotonin Cognition Disorders Signs and Symptoms Intracranial Arteriosclerosis Dopamine Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia, Vascular Dementia Delirium |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents |
Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Cardiovascular Diseases Tauopathies Central Nervous System Agents |