Imaging Predictors of Treatment Response in Depression
|ClinicalTrials.gov Identifier: NCT00367341|
Recruitment Status : Completed
First Posted : August 22, 2006
Results First Posted : January 9, 2014
Last Update Posted : January 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: escitalopram Behavioral: Cognitive Behavioral Therapy (CBT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Imaging Predictors of Treatment Response in Depression|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||July 2013|
Participants will receive treatment with escitalopram for 12 weeks.
Other Name: Lexapro
|Cognitive Behavioral Therapy||
Behavioral: Cognitive Behavioral Therapy (CBT)
CBT will include 16 1 hour sessions provided over 12 weeks.
Other Name: Talk Therapy
- Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks [ Time Frame: Measured at week 12 ]# of study participants with Hamilton Depression-17-item score less than or equal to 7.
- Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks [ Time Frame: Measured at week 12. ]Number of participants with a 50% change from Baseline on the Hamilton Depression Rating Scale-17-item score
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367341
|United States, Georgia|
|Emory University School of Medicine|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Helen Mayberg, M.D.||Emory University|