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

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ClinicalTrials.gov Identifier: NCT01119638
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Yoram Barak, Abarbanel Mental Health Center

Tracking Information
First Submitted Date  ICMJE May 6, 2010
First Posted Date  ICMJE May 7, 2010
Last Update Posted Date June 24, 2015
Study Start Date  ICMJE April 2008
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
Change in total score on the NPI. [ Time Frame: from first treatment to end of study at 6 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2010)
Change in total score on the NPI. [ Time Frame: end of study - 6 weeks ]
Change History Complete list of historical versions of study NCT01119638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
Time from initial treatment to the discontinuation of treatment for any reason. [ Time Frame: time to discontinuation for any reason ]
we shall consider any reason for stopping the study medications to be avalid reason for "discontinuation. This measure was deemed important by the NIH for dementia drug studies.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2010)
Time from initial treatment to the discontinuation of treatment for any reason.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Escitalopram Treatment for BPSD in Alzheimer's Disease in Comparison to Risperidone
Official Title  ICMJE Post Marketing Study of Escitalopram Versus Risperidone for the Treatment of Behavioral and Psychological Symptoms Amongst Alzheimer's Disease Patients
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Agitation
  • Psychosis
  • Alzheimer's Disease
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.

    Intervention: Drug: Escitalopram
  • 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.
    Intervention: Drug: Risperidone
Publications * 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. Epub 2007 Sep 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2010)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01119638
Other Study ID Numbers  ICMJE ABR-BPSD-001
CO01ABR01022008 ( Other Grant/Funding Number: Lundbeck A/S )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yoram Barak, Abarbanel Mental Health Center
Study Sponsor  ICMJE Abarbanel Mental Health Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yoram Barak, MD, MHA Abarbanel MHC, Israel.
PRS Account Abarbanel Mental Health Center
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP