Escitalopram Treatment for BPSD in Alzheimer's Disease in Comparison to Risperidone

NCT01119638 | Completed Phase 4 DMC

• 2 other identifiers: ABR-BPSD-001CO01ABR01022008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Agitation; Psychosis; Alzheimer's Disease

Keywords

Alzheimer's disease; BPSD; escitalopram; Risperidone; Agitation; Psychosis; Dementia; Elderly

Outcome Measures

Primary Outcomes (1)

• Change in total score on the NPI.

  from first treatment to end of study at 6 weeks

Secondary Outcomes (1)

• Time from initial treatment to the discontinuation of treatment for any reason.

  time to discontinuation for any reason

Study Arms (2)

Escitalopram Drug

ACTIVE COMPARATOR

Drug: Patients in the escitalopram group will receive 5 mgs/d for the first week and than 10 mgs/d till completion.

Drug: Escitalopram

Risperidone Drug

ACTIVE COMPARATOR

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

Interventions

Escitalopram DRUG

Patients in the escitalopram group will receive 5 mgs/d for the first week and than 10 mgs/d till completion.

Also known as: Cipralex

Escitalopram Drug

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.

Also known as: Risperdal

Risperidone Drug

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abarbanel Mental Health Center: lead

Study Sites (1)

Abarbanel MHC

Bat Yam, 59100, Israel

Location

Related Publications (1)

• Pollock BG, Mulsant BH, Rosen J, Mazumdar S, Blakesley RE, Houck PR, Huber KA. A double-blind comparison of citalopram and risperidone for the treatment of behavioral and psychotic symptoms associated with dementia. Am J Geriatr Psychiatry. 2007 Nov;15(11):942-52. doi: 10.1097/JGP.0b013e3180cc1ff5. Epub 2007 Sep 10.

  PMID: 17846102 BACKGROUND

MeSH Terms

Conditions

Psychomotor Agitation; Psychotic Disorders; Alzheimer Disease; Dementia

Interventions

Escitalopram; Dexetimide; Risperidone

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Pyrimidinones; Pyrimidines

Study Officials

• Yoram Barak, MD, MHA

  Abarbanel MHC, Israel.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Psychogeriatrics

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 7, 2010
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

IL (1)