Ignite Creation Date:
2024-05-05 @ 10:28 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01119638
Status:
COMPLETED
Last Update Posted:
2015-06-24
First Post:
2010-05-06
Brief Title:
Escitalopram Treatment for BPSD in Alzheimers Disease in Comparison to Risperidone
Sponsor:
Abarbanel Mental Health Center
Organization:
Abarbanel Mental Health Center
Study Overview
Official Title:
Post Marketing Study of Escitalopram Versus Risperidone for the Treatment of Behavioral and Psychological Symptoms Amongst Alzheimers Disease Patients
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EscBPSD
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CO01ABR01022008 | OTHER_GRANT | Lundbeck AS | None |