AgitationPhase 4EscBPSDNCT01119638
Escitalopram Treatment for BPSD in Alzheimer's Disease in Comparison to Risperidone
A Phase 4 study testing Escitalopram and Risperidone in people with Agitation and Psychosis, run by Abarbanel Mental Health Center at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 to 95 years
- Conditions the study is for
- Agitation, Psychosis, Alzheimer's Disease
- What is being tested?
- Escitalopram and Risperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2008to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Marketing Study of Escitalopram Versus Risperidone for the Treatment of Behavioral and Psychological Symptoms Amongst Alzheimer's Disease Patients
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.
Read the 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.
- Conditions
- Agitation, Psychosis, Alzheimer's Disease
- Being tested
- Escitalopram, Risperidone
- Keywords
- Alzheimer's disease, BPSD, escitalopram, Risperidone, Agitation, Psychosis, Dementia, Elderly
- Medical subject headings
- Psychomotor Agitation, Psychotic Disorders, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Cipralex
Patients in the escitalopram group will receive 5 mgs/d for the first week and than 10 mgs/d till completion.
RisperidoneDrug
Also called Risperdal
Patients in the risperidone group will receive 0.5 mgs/d for the first week and than 1.0 mg/d till completion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total score on the NPI.
Measured: 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.
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.
Measured: time to discontinuation for any reason
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startApr 2008
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abarbanel Mental Health Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yoram Barak, Abarbanel Mental Health Center
- Investigators
- Yoram Barak, MD, MHA, Principal investigator, Abarbanel MHC, Israel.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119638
- Sponsor's protocol ID
- ABR-BPSD-001
- Other IDs
- CO01ABR01022008
- Acronym
- EscBPSD
- Status last verified
- Jun 2015
- First submitted
- 6 May 2010
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1097/JGP.0b013e3180cc1ff5. Epub 2007 Sep 10.
PubMed 17846102
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Study of Escitalopram Versus Risperidone for the Treatment of Behavioral and Psychological Symptoms Amongst Alzheimer's Disease Patients
- ClinicalTrials.gov ID
- NCT01119638
- Acronym / sponsor ID
- EscBPSD / ABR-BPSD-001
- Conditions
- Agitation, Psychosis, Alzheimer's Disease
- Keywords
- Alzheimer's disease, BPSD, escitalopram, Risperidone, Agitation, Psychosis, Dementia, Elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Abarbanel Mental Health CenterOther government
- Study start
- Apr 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 7 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram Drug | Active comparator | Drug: EscitalopramDrug: Patients in the escitalopram group will receive 5 mgs/d for the first week and than 10 mgs/d till completion. |
| Risperidone Drug | Active comparator | Drug: RisperidonePatients in the risperidone group will receive 0.5 mgs/d for the first week and than 1.0 mg/d till completion. |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramAlso: CipralexPatients in the escitalopram group will receive 5 mgs/d for the first week and than 10 mgs/d till completion. | Drug | Escitalopram Drug |
| RisperidoneAlso: RisperdalPatients in the risperidone group will receive 0.5 mgs/d for the first week and than 1.0 mg/d till completion. | Drug | Risperidone Drug |
Primary outcome
Change in total score on the NPI.
Time frame: from first treatment to end of study at 6 weeks
1 secondary outcome
Time from initial treatment to the discontinuation of treatment for any reason.
Time frame: time to discontinuation for any reason
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Background: PubMed 17846102Pollock 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoram Barak, MD, MHA principal investigator
Abarbanel MHC, Israel.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Escitalopram and Risperidone in people with Agitation and Psychosis, run by Abarbanel Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total score on the NPI. (time frame: from first treatment to end of study at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01119638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.