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Sponsors and Collaborators: |
Emory University National Institute of Mental Health (NIMH) |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00367341 |
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 the alternative intervention. 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.
Condition | Intervention |
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Major Depressive Disorder |
Drug: escitalopram Behavioral: Cognitive Behavioral Therapy (CBT) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Imaging Predictors of Treatment Response in Depression |
Estimated Enrollment: | 100 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 21 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Co-morbid DSM-IV Axis I Diagnoses
Use of concomitant medications with the exception of:
Contact: Rebecca De Mayo, MA | 404-727-5602 | rdemayo@emory.edu |
Contact: Andrea Barrocas | 404-727-9228 | abarroc@emory.edu |
United States, Georgia | |
Emory University School of Medicine | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Principal Investigator: Helen Mayberg, M.D. | |
Sub-Investigator: Boadie Dunlop, M.D. | |
Sub-Investigator: Edward Craighead, Ph. D | |
Sub-Investigator: Jeffrey Newport |
Principal Investigator: | Helen Mayberg, M.D. | Emory University |
Responsible Party: | Emory University ( Dr. Helen Mayberg ) |
Study ID Numbers: | #872-2004 |
Study First Received: | August 18, 2006 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00367341 |
Health Authority: | United States: Institutional Review Board |
Depression, Treatment, Imaging |
Depression Mental Disorders Mood Disorders Depressive Disorder, Major Dexetimide |
Depressive Disorder Citalopram Serotonin Behavioral Symptoms |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |