Escitalopram Treatment for Behavioral and Psychological Symptoms of Dementia (BPSD) in Alzheimer's Disease in Comparison to Risperidone (EscBPSD)

This study has been completed.
Sponsor:
Information provided by:
Abarbanel Mental Health Center
ClinicalTrials.gov Identifier:
NCT01119638
First received: May 6, 2010
Last updated: NA
Last verified: December 2007
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Abarbanel Mental Health Center:

Primary Outcome Measures:
  • Change in total score on the NPI. [ Time Frame: end of study - 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119638

Locations
Israel
Abarbanel MHC
Bat-Yam, Israel, 59100
Sponsors and Collaborators
Abarbanel Mental Health Center
Investigators
Principal Investigator: Yoram Barak, MD, MHA Abarbanel MHC, Israel.
  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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Citalopram
Dexetimide
Risperidone
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Cholinergic Agents
Cholinergic Antagonists
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 23, 2014