DepressionPhase 4NCT01477268
Cognitive Correlates of Antidepressant Treatment Response in Elders
A Phase 4 study testing Zoloft (antidepressant) in people with Depression, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Major depression is a very common health problem affecting older persons. The present standard of treatment is with medications called "antidepressants". Antidepressants have been studied extensively in older persons with normal brain function and have been shown to be effective. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Zoloft (antidepressant)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2007to Oct 2009
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- above the age of 65,
- speak English fluently,
- experience depression, AND
- not yet on active treatment.
Who cannot join
- active delirium,
- substance abuse,
- mental illness other than major depression,
- active CNS disease,
- unstable systematic medical disease, OR
- current of past psychotic disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Impact of Dementia and Executive Impairment on Antidepressant Treatment Response in Older Persons
Major depression is a very common health problem affecting older persons. The present standard of treatment is with medications called "antidepressants". Antidepressants have been studied extensively in older persons with normal brain function and have been shown to be effective. However, certain types of brain dysfunction called "executive impairment" (inability to do higher order thinking) may lead to poor treatment outcomes. This study will compare how older depressed people with different levels of executive impairment respond differently to standard antidepressant treatment. Knowing this information will lead to more rational targeting of available treatments, leading to improved treatment outcomes.
- Conditions
- Depression
- Being tested
- Zoloft (antidepressant)
- Keywords
- antidepressants, depression, zoloft, psychiatry, psychology
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoloft (antidepressant)Drug
Also called Sertraline
Zoloft 50-200 mg po od x 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| zoloft | Other | Both arms of the study will include zoloft. However, the treatment response to zoloft will be compared in two different subgroups. Receives: Drug: Zoloft (antidepressant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression
Measured: June 1, 2007 - June 1, 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJun 2007
- Primary completionApr 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Corinne Fischer, MD, Principal investigator, St. Michaels Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477268
- Sponsor's protocol ID
- 06-296
- Status last verified
- May 2011
- First submitted
- 9 Jun 2009
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Impact of Dementia and Executive Impairment on Antidepressant Treatment Response in Older Persons
- ClinicalTrials.gov ID
- NCT01477268
- Acronym / sponsor ID
- 06-296
- Conditions
- Depression
- Keywords
- antidepressants, depression, zoloft, psychiatry, psychology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Nov 2011 (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.
Major depression is a very common health problem affecting older persons. The present standard of treatment is with medications called "antidepressants". Antidepressants have been studied extensively in older persons with normal brain function and have been shown to be effective. However, certain types of brain dysfunction called "executive impairment" (inability to do higher order thinking) may lead to poor treatment outcomes. This study will compare how older depressed people with different levels of executive impairment respond differently to standard antidepressant treatment. Knowing this information will lead to more rational targeting of available treatments, leading to improved treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zoloft | Other | Drug: Zoloft (antidepressant)Both arms of the study will include zoloft. However, the treatment response to zoloft will be compared in two different subgroups. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- above the age of 65,
- speak English fluently,
- experience depression, AND
- not yet on active treatment.
Key exclusion criteria (6 listed)
- active delirium,
- substance abuse,
- mental illness other than major depression,
- active CNS disease,
- unstable systematic medical disease, OR
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 |
|---|---|---|
| Zoloft (antidepressant)Also: SertralineZoloft 50-200 mg po od x 12 weeks | Drug | zoloft |
Primary outcome
depression
Time frame: June 1, 2007 - June 1, 2008
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 22 Nov 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.
Corinne Fischer, MD principal investigator
St. Michaels Hospital
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 Zoloft (antidepressant) in people with Depression, run by Unity Health Toronto at 1 site 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 6 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 22 Nov 2011. 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 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 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?
depression (time frame: June 1, 2007 - June 1, 2008). 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 22 Nov 2011.