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NCT02332291 · ClinicalTrials.gov registry record · Phase 4
Connectivity Affecting the Antidepressant REsponse Study
A Phase 4 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 95
- Enrollment target
NCT02332291 is a Phase 4 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 95 participants.
The verdict
NCT02332291, a Phase 4 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 95 participants
- Enrollment target
Study Summary
It can be difficult to achieve remission in individuals with late-life depression (LLD) and they often require aggressive treatment. This challenge is in part due to age-related vascular changes that are common in LLD. Successful antidepressant treatment involve changes across affective, cognitive, and default mode networks. We hypothesize that in LLD, vascular disease adversely affects response to antidepressants by disrupting connectivity of these networks. The primary goal of this project is to characterize how focal vascular damage affects regional connectivity and response to antidepressants. Based on past work and pilot data, we a priori focus on the cingulum bundle and uncinate fasciculus. These key fiber bundles connect frontal, temporal, and cingulate regions involved in cognition and affective responses. Our central hypothesis is that ischemic damage to the cingulum bundle and uncinate fasciculus contributes to structural and functional connectivity deficits of those tracts. This results in a disconnection effect that alters the function of connected regions. In turn, this increases the risk of a poor response to antidepressants. Our approach is to enroll up to 130 adults over age 60 years with a diagnosis of Major Depressive Disorder. Subjects will complete clinical evaluation, cognitive testing, and MRI/functional MRI (fMRI) sessions, including an fMRI emotional oddball task that includes attentional and affective components. Participants will be stratified by cerebral lesion severity and randomized in a 2:1 ratio to a double-blinded 8-week trial of escitalopram or matching placebo. Those who do not remit will transition to an 8-week trial of open-label bupropion, an antidepressant with a different mechanism of action. This will allow us to determine if different and distinct circuit deficits affect response to antidepressants with different mechanisms of action while also accounting for the placebo response.
Interventions
- DRUG Escitalopram
- DRUG Bupropion XL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2015-04 |
| Est. Completion | 2020-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02332291
The ClinicalTrials.gov registry entry for NCT02332291 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Escitalopram is the first listed.
NCT02332291 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02332291 about?
NCT02332291 is a clinical study titled "Connectivity Affecting the Antidepressant REsponse Study". It can be difficult to achieve remission in individuals with late-life depression (LLD) and they often require aggressive treatment. This challenge is in part due to age-related vascular changes that are common in LLD. Successful antidepressant treatment involve changes across affective, cognitive, ...
What is the current status of trial NCT02332291?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 95 participants. The study started on 2015-04. Estimated completion is 2020-08.
What interventions are being tested in trial NCT02332291?
The interventions under investigation include: Escitalopram (DRUG), Bupropion XL (DRUG).
Who is sponsoring clinical trial NCT02332291?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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