Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367341
Status:
COMPLETED
Last Update Posted:
2014-01-09
First Post:
2006-08-18
Brief Title:
Imaging Predictors of Treatment Response in Depression
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Imaging Predictors of Treatment Response in Depression
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
While there are many effective options for treating a major depressive episode there are no clinical markers that predict the likelihood of remission with an initial trial of either an antidepressant medication or psychotherapy More critically there are also no reliable predictors that might anticipate failure to such standard treatments either alone or in combination This project will characterize imaging-based brain subtypes that distinguish groups of depressed patients who later remit or not to SSRI pharmacotherapy or cognitive behavior therapy CBT respectively To define these subtypes a prospectively-treated cohort of 100 patients will be randomized to receive either escitalopram s-CIT or CBT for the first 12 weeks with non-remitters to either first treatment crossed over to receive an additional 12 weeks of treatment with combined treatment Non-remitters to both treatments will thus define a relatively treatment resistant third subgroup Resting-state 18F-fluoro-deoxyglucose FDG positron emission tomography PET scans will be acquired prior to initiating antidepressant therapy with pre-treatment scan patterns associated with three possible outcomes CBT remission s-CIT remission and non-remission to both assessed using multivariate analytic methods A second PET scan acquired early in the treatment course will be used to assess the likelihood of response to the specific treatment first assigned The proposed studies are a first step towards defining brain-based biomarkers predictive of differential treatment outcome in major depression most critically patterns distinguishing patients at risk for treatment resistance Identification of such biomarkers has additional implications for future testing of novel therapies in patients with distinct brain signatures including development of evidence-based treatment algorithms for individual patients
Detailed Description:
SPECIFIC AIMS Aim 1 To define baseline regional glucose metabolic patterns measured using FDG PET associated with differential clinical remission to each of two well-established randomly delivered first-line antidepressant treatments-the SSRI escitalopram s-CIT or cognitive behavioral therapy CBT with cross-over treatment for non-remitters sequential course of treatment model
Aim 2 To define metabolic change patterns occurring early in the course of both s-CIT and CBT associated with successful and unsuccessful clinical remission to each intervention
Aim 2 To define metabolic change patterns occurring early in the course of both s-CIT and CBT associated with successful and unsuccessful clinical remission to each intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None