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Imaging Predictors of Treatment Response in Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00367341
First Posted: August 22, 2006
Last Update Posted: January 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Helen Mayberg, Emory University
Results First Submitted: November 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: escitalopram
Behavioral: Cognitive Behavioral Therapy (CBT)

  Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Escitalopram escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
Cognitive Behavioral Therapy Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
Total Total of all reporting groups

Baseline Measures
   Escitalopram   Cognitive Behavioral Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   40   82 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   42   40   82 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.2  (6.8)   42.2  (9.5)   41.68  (8.22) 
Gender 
[Units: Participants]
     
Female   26   22   48 
Male   16   18   34 
Region of Enrollment 
[Units: Participants]
     
United States   42   40   82 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks   [ Time Frame: Measured at week 12. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information