Depressive DisorderPhase 3NCT00488670
Escitalopram and Depression in Elderly Alzheimer's Patients
A Phase 3 study testing Escitalopram in people with Depressive Disorder, run by University of British Columbia at 2 sites in Canada.
Trial summary
To investigate the effect of Escitalopram in a large and diverse of dementia patients suffering from depression. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Escitalopram
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2010to Jun 2011
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 50 years
- Male \& female
- Alzheimer's disease
- Depressive episode
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Mt. St. Joseph's Hospital
Vancouver, British Columbia
Vancouver General Hospital
Vancouver, British Columbia
About this study
Official title: An Open-label Study of Escitalopram in the Treatment of Major Depressive Disorder in Elderly Patients With Alzheimer's Disease
To investigate the effect of Escitalopram in a large and diverse of dementia patients suffering from depression.
Read the detailed description
This study will assess the efficacy, tolerability, and safety of escitalopram in the treatment of Major Depressive Disorder in patients with Alzheimer's disease over a 24-week period. It will also assess the efficacy and tolerability of escitalopram after 12 weeks of treatment.
- Conditions
- Depressive Disorder
- Being tested
- Escitalopram
- Keywords
- Alzheimer's disease, elderly, open-label, escitalopram
- Medical subject headings
- Depressive Disorder, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
See Detailed Description.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cornell Scale for Depression in Dementia (CSDD) from baseline.
Secondary outcomes (1)
Montgomery-Åsberg Depression Rating Scale; Neuropsychiatric Inventory; Alzheimer's Disease Cooperative Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startDec 2010
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Dr. Rabheru left VCH last year and the study was cancelled according to his research coordinator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Kiran Rabheru, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488670
- Sponsor's protocol ID
- H07-00050
- Status last verified
- Jun 2011
- First submitted
- 18 Jun 2007
- Last updated
- 6 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study of Escitalopram in the Treatment of Major Depressive Disorder in Elderly Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00488670
- Acronym / sponsor ID
- H07-00050
- Conditions
- Depressive Disorder
- Keywords
- Alzheimer's disease, elderly, open-label, escitalopram
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dr. Rabheru left VCH last year and the study was cancelled according to his research coordinator.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Jun 2007 (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.
To investigate the effect of Escitalopram in a large and diverse of dementia patients suffering from depression.
Detailed description
This study will assess the efficacy, tolerability, and safety of escitalopram in the treatment of Major Depressive Disorder in patients with Alzheimer's disease over a 24-week period. It will also assess the efficacy and tolerability of escitalopram after 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 50 years
- Male \& female
- Alzheimer's disease
- Depressive episode
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EscitalopramSee Detailed Description. | Drug | – |
Primary outcome
Change in Cornell Scale for Depression in Dementia (CSDD) from baseline.
1 secondary outcome
Montgomery-Åsberg Depression Rating Scale; Neuropsychiatric Inventory; Alzheimer's Disease Cooperative Study
Results and safety
The study was stopped early (reason given: Dr. Rabheru left VCH last year and the study was cancelled according to his research coordinator.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2011.
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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.
Kiran Rabheru, MD principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Escitalopram in people with Depressive Disorder, run by University of British Columbia at 2 sites in Canada.
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 0 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: stopped early, as of the sponsor's last update on 6 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Dr. Rabheru left VCH last year and the study was cancelled according to his research coordinator.). Results are not available in the source record.
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 Cornell Scale for Depression in Dementia (CSDD) from baseline.. 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 6 Jun 2011.