Escitalopram Treatment for Behavioral and Psychological Symptoms of Dementia (BPSD) in Alzheimer's Disease in Comparison to Risperidone (EscBPSD)
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Purpose
Behavioral and psychological symptoms of dementia (BPSD) are among the most distressing manifestations of dementia. Pharmacotherapy is frequently used and especially in institutional settings. Current guidelines recommend the use of second-generation antipsychotics (SGAs). Nonetheless, there are concerns regarding both their safety and effectiveness in patients with dementia. Inconclusive evidence support the use of other psychoactive agents such as SSRI antidepressants or cognitive enhancers.
In two published studies citalopram was as efficacious as, but better tolerated than perphenazine or risperidone in patients with BPSD.
Thus, with proven efficacy and a beneficial safety profile the evaluation of the use of escitalopram for BPSD is warranted.
| Condition | Intervention | Phase |
|---|---|---|
|
Agitation Psychosis Alzheimer's Disease |
Drug: Escitalopram Drug: Risperidone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Post Marketing Study of Escitalopram Versus Risperidone for the Treatment of Behavioral and Psychological Symptoms Amongst Alzheimer's Disease Patients |
- Change in total score on the NPI. [ Time Frame: end of study - 6 weeks ] [ Designated as safety issue: No ]
- Time from initial treatment to the discontinuation of treatment for any reason. [ Designated as safety issue: Yes ]
| Enrollment: | 40 |
| Study Start Date: | April 2008 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Escitalopram Drug
Drug: Patients in the escitalopram group will receive 5 mgs/d for the first week and than 10 mgs/d till completion. |
Drug: Escitalopram
Patients in the escitalopram group will receive 5 mgs/d for the first week and than 10 mgs/d till completion.
Other Name: Cipralex
|
|
Active Comparator: Risperidone Drug
Patients in the risperidone group will receive 0.5 mgs/d for the first week and than 1.0 mg/d till completion.
|
Drug: Risperidone
Patients in the risperidone group will receive 0.5 mgs/d for the first week and than 1.0 mg/d till completion.
Other Name: Risperdal
|
Detailed Description:
Behavioral and psychological symptoms of dementia (BPSD) as agitation or psychosis are among the most distressing manifestations of dementia. The evidence-based management of these symptoms includes the search for treatable physical and environmental precipitants, support and psychoeducation for primary caregivers and psychosocial interventions. Nevertheless, pharmacotherapy is frequently used and especially in institutional settings. Current guidelines recommend the use of second-generation antipsychotics (SGAs). Nonetheless, there are concerns regarding both their safety and effectiveness in patients with dementia. Recent research has resulted in a 'black-box" warning concerning the safety of using SGAs for BPSD. Sparse and inconclusive evidence support the use of other psychoactive agents such as SSRI antidepressants or cognitive enhancers.
In two published randomized controlled trials, citalopram was more efficacious than placebo and as efficacious as, but better tolerated than perphenazine or risperidone in patients with dementia hospitalized for the treatment of agitation or psychosis.
Thus, with proven efficacy and a beneficial safety profile the evaluation of the use of escitalopram for BPSD is warranted.
A 6-week parallel groups, randomized, controlled trial in patients with dementia hospitalized because of behavioral symptoms will be conducted at the Abarbanel MHC.
Participants will be consecutively recruited on an inpatient unit. Randomization will be based on a table of random numbers held centrally by an uninvolved physician.
The study will be of a "double-blind" design. All medications in identical packaging will be distributed to the ward from a central pharmacy.
Eligibility| Ages Eligible for Study: | 55 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible participants will fulfill criteria for dementia of the Alzheimer's type (according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition). The score on the Mini-Mental State Examination (MMSE) has to be between 5 and 26.
Eligible patients will suffer from delusions, hallucinations, aggression, or agitation that developed after the onset of dementia and is severe enough to disrupt their functioning and, in the opinion of the study physicians, to justify treatment with antipsychotic drugs.
Signs and symptoms of psychosis, aggression, or agitation will have to occur nearly daily during the week prior to enrollment.
A frequency rating of "often" or "more frequently" and a severity rating of at least "moderate" are required for delusions, hallucinations, agitation, or "aberrant motor behavior" in the Neuropsychiatric Inventory (NPI).
Exclusion Criteria:
Patients will be excluded if they had received a diagnosis of a primary psychotic disorder (e.g., schizophrenia), delirium, other dementia. Patients will also be excluded if they were going to receive treatment with a cholinesterase inhibitor or antidepressant medication, had previously been treated with escitalopram for BPSD, or had contraindications to the two study drugs.
Contacts and Locations More Information
Publications:
| Responsible Party: | Prof Yoram Barak, Abarbanel MHC |
| ClinicalTrials.gov Identifier: | NCT01119638 History of Changes |
| Other Study ID Numbers: | ABR-BPSD-001, CO01ABR01022008 |
| Study First Received: | May 6, 2010 |
| Last Updated: | May 6, 2010 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Abarbanel Mental Health Center:
|
Alzheimer's disease BPSD escitalopram Risperidone |
Agitation Psychosis Dementia Elderly |
Additional relevant MeSH terms:
|
Alzheimer Disease Mental Disorders Psychotic Disorders Psychomotor Agitation Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Schizophrenia and Disorders with Psychotic Features Dyskinesias Neurologic Manifestations Psychomotor Disorders |
Neurobehavioral Manifestations Signs and Symptoms Dexetimide Citalopram Risperidone Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013