DepressionNCT01751828
Late-life Depression and Cerebral Perfusion
A study testing Sertraline in people with Depression, run by Vanderbilt University at 1 site in United States.
Trial summary
The long-term goal is to determine if decreased blood flow to the brain (cerebral hypoperfusion) is predictive of antidepressant outcomes in late-life depression (LLD). Studies in younger adult report that successful antidepressant treatment is associated with increases in cerebral blood flow, with no change in blood… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Sertraline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Aug 2013
- Phase
- Interventional
- 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
- Age 60 years or older.
- Current diagnosis of major depressive disorder (DSM-IV-TR), recurrent or chronic, without psychotic features
- Minimum depression severity of Montgomery Asberg Depression Rating Scale (MADRS) score ≥ 15
- Cognitively intact by Montreal Cognitive Assessment (MoCA) score ≥ 23
- Ability to read and write English
Who cannot join
- Other current or past psychiatric diagnoses
- Any use of illicit substances or abuse of prescription medications
- Presence of acute suicidality
- Current or past psychotic symptoms
- Known primary neurological disorder, including dementia
- Chronic untreated medical disorders where treatment is warranted
Show all 12Show fewer
- Any contraindication to MRI, such as metal in the body
- Electroconvulsive therapy in the last 6 months
- Use of antidepressants or other psychiatric medications in the last month.
- Known allergy to sertraline
- A failed therapeutic trial of sertraline in the current depressive episode
- Current or planned psychotherapy
Trial locations and contacts
1 site in 1 country.
About this study
The long-term goal is to determine if decreased blood flow to the brain (cerebral hypoperfusion) is predictive of antidepressant outcomes in late-life depression (LLD). Studies in younger adult report that successful antidepressant treatment is associated with increases in cerebral blood flow, with no change in blood flow being observed in nonresponders. Thus cerebral hypoperfusion may be a biomarker of poor response to antidepressants. In LLD, this may occur secondarily to underlying vascular disease. If LLD is characterized by cerebral hypoperfusion and it does have predictive power to identify individuals who will poorly respond to conventional antidepressants, this would support the study of interventions that improve cerebral perfusion and may improve antidepressant outcomes.
As an initial step in this research, this pilot study will utilize MRI to examine if resting blood flow deficits predict and persist with antidepressant nonremission in an elderly population. The rationale for this proposal is that it will guide the design and power requirements of a larger, definitive trial examining the relationship between cerebral perfusion and depression outcomes. Importantly, support for this mechanism being linked to LLD would also support studies examining the antidepressant efficacy of drugs that may improve cerebral perfusion.
Read more
The primary purpose of this pilot study is a) to demonstrate feasibility by recruiting, scanning, and treating depressed elders; and b) to acquire preliminary data for competitive grant submissions.
SPECIFIC AIM: To use MRI to test for differences in cerebral perfusion between individuals who do and do not remit to a 8-week course of sertraline.
Read the detailed description
After providing informed consent, participants will complete brain MRI and memory testing. If they are currently taking an antidepressant and are not doing well on it, they will be taken off it. Participants will then start sertraline, a commercially available antidepressants. They will be monitored for response and side effects for 8 weeks and doses adjusted as needed. After the study, we will examine how differences in brain blood flow may predict who does and does not respond to sertraline.
- Conditions
- Depression
- Being tested
- Sertraline
- Keywords
- Depression, Major Depressive Disorder
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft
| Study group | Role | What they receive |
|---|---|---|
| Sertraline | Experimental | Open-label sertraline, 8 week trial, dosing from 50mg to 200mg daily. Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale
Measured: 8 weeks
Secondary outcomes (1)
Quick Inventory of Depressive Symptoms (QIDS)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2013 (estimated)
Why it stopped: This was an initial unfunded pilot project stopped after similar studies were funded.
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.
- 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Warren Taylor, Vanderbilt University
- Investigators
- Warren D Taylor, MD, MHSc, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751828
- Sponsor's protocol ID
- 121648
- Status last verified
- Jul 2013
- First submitted
- 12 Dec 2012
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late-life Depression and Cerebral Perfusion
- ClinicalTrials.gov ID
- NCT01751828
- Acronym / sponsor ID
- 121648
- Conditions
- Depression
- Keywords
- Depression, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This was an initial unfunded pilot project stopped after similar studies were funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2013 (estimated)
- First posted
- 18 Dec 2012 (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 long-term goal is to determine if decreased blood flow to the brain (cerebral hypoperfusion) is predictive of antidepressant outcomes in late-life depression (LLD). Studies in younger adult report that successful antidepressant treatment is associated with increases in cerebral blood flow, with no change in blood flow being observed in nonresponders. Thus cerebral hypoperfusion may be a biomarker of poor response to antidepressants. In LLD, this may occur secondarily to underlying vascular disease. If LLD is characterized by cerebral hypoperfusion and it does have predictive power to identify individuals who will poorly respond to conventional antidepressants, this would support the study of interventions that improve cerebral perfusion and may improve antidepressant outcomes.
As an initial step in this research, this pilot study will utilize MRI to examine if resting blood flow deficits predict and persist with antidepressant nonremission in an elderly population. The rationale for this proposal is that it will guide the design and power requirements of a larger, definitive trial examining the relationship between cerebral perfusion and depression outcomes. Importantly, support for this mechanism being linked to LLD would also support studies examining the antidepressant efficacy of drugs that may improve cerebral perfusion.
The primary purpose of this pilot study is a) to demonstrate feasibility by recruiting, scanning, and treating depressed elders; and b) to acquire preliminary data for competitive grant submissions.
SPECIFIC AIM: To use MRI to test for differences in cerebral perfusion between individuals who do and do not remit to a 8-week course of sertraline.
Detailed description
After providing informed consent, participants will complete brain MRI and memory testing. If they are currently taking an antidepressant and are not doing well on it, they will be taken off it. Participants will then start sertraline, a commercially available antidepressants. They will be monitored for response and side effects for 8 weeks and doses adjusted as needed. After the study, we will examine how differences in brain blood flow may predict who does and does not respond to sertraline.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sertraline | Experimental | Drug: SertralineOpen-label sertraline, 8 week trial, dosing from 50mg to 200mg daily. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 60 years or older.
- Current diagnosis of major depressive disorder (DSM-IV-TR), recurrent or chronic, without psychotic features
- Minimum depression severity of Montgomery Asberg Depression Rating Scale (MADRS) score ≥ 15
- Cognitively intact by Montreal Cognitive Assessment (MoCA) score ≥ 23
- Ability to read and write English
Key exclusion criteria (12 listed)
- Other current or past psychiatric diagnoses
- Any use of illicit substances or abuse of prescription medications
- Presence of acute suicidality
- Current or past psychotic symptoms
- Known primary neurological disorder, including dementia
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 |
|---|---|---|
| SertralineAlso: Zoloft | Drug | Sertraline |
Primary outcome
Montgomery-Asberg Depression Rating Scale
Time frame: 8 weeks
1 secondary outcome
Quick Inventory of Depressive Symptoms (QIDS)
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
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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.
Warren D Taylor, MD, MHSc principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sertraline in people with Depression, run by Vanderbilt University at 1 site in United States.
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 5 inclusion and 12 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: withdrawn, as of the sponsor's last update on 31 Jul 2013. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Montgomery-Asberg Depression Rating Scale (time frame: 8 weeks). 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 31 Jul 2013.