Depressive SyndromePhase 4NCT00229333
Study of Escitalopram Versus Placebo in the Treatment of Depressive Syndrome in Alzheimer's Disease, Vascular Dementia, and Mixed Vascular and Alzheimer's Dementia
A Phase 4 study testing Escitalopram in people with Depressive Syndrome, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The goal of the present study is to compare the effectiveness of the active (S)-enantiomer of citalopram, escitalopram with placebo in the treatment of patients with depressive syndrome complicating Alzheimer's dementia (AD), vascular dementia (VD) or mixed dementia (MD), for 8 weeks of double-blind treatment. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depressive Syndrome
- What is being tested?
- Escitalopram
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2004to not given
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject meets criteria for the diagnosis of Alzheimer's dementia, or vascular dementia, or mixed alzheimer's and vascular dementia, according to Diagnostic and Statistical for Mental Disorders, Fourth Edition (DSM-IV) criteria.
- Subject meets the following criteria for depressive syndrome: DSM-IV criteria for major depressive episode; and Cornell Scale of Depression in Dementia is 18 or more.
- The depressive syndrome has been present for at least two weeks preceding study entry (Visit 1).
- The depressive syndrome must be at least moderate in severity at Visit 1 and Visit 2 (cause the subject impairment in functional capacity) and in the opinion of the investigator require pharmacological intervention.
- Score on the Mini Mental State Examination (MMSE) of 10-26 at Visit 1 and at Visit 2.
- Other possible reasons for the subject's depressive symptoms, for example, medications or other medical conditions (such as pain, infection, cancer of the pancreas, etc.), have been excluded as an etiology.
Who cannot join
- General Exclusion Criteria:
- Subjects who need placebo run-in period, and/or their caregivers are unable to comply with Study Period I medication to the extent that drug compliance in the remainder of the study would be compromised as determined by the investigator.
- Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- Diagnostic Exclusion Criteria:
- Schizophrenia
- Subjects who are judged clinically to be at serious suicidal risk at Visit 1.
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- Subjects who have clinically significant psychotic symptoms at Visit 1.
- Subject has a serious neurological condition other than AD, VD or MD including, but not limited to: traumatic (head-brain) dementia, space-occupying lesion, relevant structural abnormalities on brain imaging, etc.
- Subject who underwent CVA for 3 months.
- Subject is doing well on a current antidepressant drug regimen.
- Exclusionary Concurrent or Historical Illness:
- Subjects with severe hepatic or renal insufficiency.
- Hypo/hyperthyroidism
- B-12 deficiency
- Exclusionary Concomitant or Historical Medications:
- Participation in a clinical trial of another investigational drug within 30 days prior to study entry (Visit 1) and/or any concurrent investigational study.
- Subjects with a history of severe adverse reaction to citalopram or escitalopram.
- Concomitant medication as specified.
- Previous treatment with escitalopram unless, in the opinion of the investigator, the patient's previous treatment was inadequate in dose and/or duration to provide an accurate assessment of the therapy.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 52621
Anna Sverdlik, MD, 972-54-4718424, annasver@hotmail.com
Aviva Cohen, BA, 972-3-5305910
About this study
Official title: Exploratory Study to Assess the Efficacy of Escitalopram Versus Placebo in the Treatment of Depressive Syndrome in Alzheimer's Disease, Vascular Dementia and Mixed Vascular and Alzheimer's Dementia
The goal of the present study is to compare the effectiveness of the active (S)-enantiomer of citalopram, escitalopram with placebo in the treatment of patients with depressive syndrome complicating Alzheimer's dementia (AD), vascular dementia (VD) or mixed dementia (MD), for 8 weeks of double-blind treatment.
- Conditions
- Depressive Syndrome
- Being tested
- Escitalopram
- Keywords
- Escitalopram, Depression, Dementia, Treatment, Depressive Syndrome in Alzheimer's Disease, Depressive Syndrome in Vascular Dementia, Depressive Syndrome in Mixed Vascular and Alzheimer's Dementia
- Medical subject headings
- Depressive Disorder, Depression, Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cornell Scale for Depression in Dementia (CSDD) total score
Secondary outcomes (1)
Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield et al. 1989)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SyndromeStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- H. Lundbeck A/S
- Investigators
- Anna Sverdlik, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229333
- Sponsor's protocol ID
- SHEBA-03-3124-AS-CTIL
- Status last verified
- Aug 2006
- First submitted
- 27 Sep 2005
- Last updated
- 29 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study to Assess the Efficacy of Escitalopram Versus Placebo in the Treatment of Depressive Syndrome in Alzheimer's Disease, Vascular Dementia and Mixed Vascular and Alzheimer's Dementia
- ClinicalTrials.gov ID
- NCT00229333
- Acronym / sponsor ID
- SHEBA-03-3124-AS-CTIL
- Conditions
- Depressive Syndrome
- Keywords
- Escitalopram, Depression, Dementia, Treatment, Depressive Syndrome in Alzheimer's Disease, Depressive Syndrome in Vascular Dementia, Depressive Syndrome in Mixed Vascular and Alzheimer's Dementia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- H. Lundbeck A/S
- Study start
- Dec 2004
- First posted
- 29 Sep 2005 (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.
The goal of the present study is to compare the effectiveness of the active (S)-enantiomer of citalopram, escitalopram with placebo in the treatment of patients with depressive syndrome complicating Alzheimer's dementia (AD), vascular dementia (VD) or mixed dementia (MD), for 8 weeks of double-blind treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject meets criteria for the diagnosis of Alzheimer's dementia, or vascular dementia, or mixed alzheimer's and vascular dementia, according to Diagnostic and Statistical for Mental Disorders, Fourth Edition (DSM-IV) criteria.
- Subject meets the following criteria for depressive syndrome: DSM-IV criteria for major depressive episode; and Cornell Scale of Depression in Dementia is 18 or more.
- The depressive syndrome has been present for at least two weeks preceding study entry (Visit 1).
- The depressive syndrome must be at least moderate in severity at Visit 1 and Visit 2 (cause the subject impairment in functional capacity) and in the opinion of the investigator require pharmacological intervention.
- Score on the Mini Mental State Examination (MMSE) of 10-26 at Visit 1 and at Visit 2.
Key exclusion criteria (19 listed)
- Subjects who need placebo run-in period, and/or their caregivers are unable to comply with Study Period I medication to the extent that drug compliance in the remainder of the study would be compromised as determined by the investigator.
- Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
- Schizophrenia
- Subjects who are judged clinically to be at serious suicidal risk at Visit 1.
- Subjects who have clinically significant psychotic symptoms at Visit 1.
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 |
|---|---|---|
| Escitalopram | Drug | – |
Primary outcome
Cornell Scale for Depression in Dementia (CSDD) total score
1 secondary outcome
Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield et al. 1989)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2006.
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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.
Anna Sverdlik, MD principal investigator
Sheba Medical Center
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 in people with Depressive Syndrome, run by Sheba Medical 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 6 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 29 Aug 2006. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Sverdlik, MD (972-54-4718424, annasver@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cornell Scale for Depression in Dementia (CSDD) total score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2006.