Imaging Predictors of Treatment Response in Depression
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|