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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Helen Mayberg, Emory University

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)
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Escitalopram Cognitive Behavioral Therapy
Hide Arm/Group Description escitalopram : Participants will receive treatment with escitalopram for 12 weeks. Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
Period Title: Overall Study
Started 42 40
Completed 40 40
Not Completed 2 0
Reason Not Completed
Physician Decision             1             0
Protocol Violation             1             0
Arm/Group Title Escitalopram Cognitive Behavioral Therapy Total
Hide Arm/Group Description escitalopram : Participants will receive treatment with escitalopram for 12 weeks. Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 42 40 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 40 participants 82 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
42
 100.0%
40
 100.0%
82
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 40 participants 82 participants
41.2  (6.8) 42.2  (9.5) 41.68  (8.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 40 participants 82 participants
Female
26
  61.9%
22
  55.0%
48
  58.5%
Male
16
  38.1%
18
  45.0%
34
  41.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 40 participants 82 participants
42 40 82
1.Primary Outcome
Title Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks
Hide Description # of study participants with Hamilton Depression-17-item score less than or equal to 7.
Time Frame Measured at week 12
Hide Outcome Measure Data
Hide Analysis Population Description
completed study participants in 12-week-trial
Arm/Group Title Escitalopram Cognitive Behavioral Therapy
Hide Arm/Group Description:
escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
Overall Number of Participants Analyzed 32 31
Measure Type: Number
Unit of Measure: participants
12 12
2.Secondary Outcome
Title Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks
Hide Description Number of participants with a 50% change from Baseline on the Hamilton Depression Rating Scale-17-item score
Time Frame Measured at week 12.
Hide Outcome Measure Data
Hide Analysis Population Description
completers
Arm/Group Title Escitalopram Cognitive Behavioral Therapy
Hide Arm/Group Description:
escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
Overall Number of Participants Analyzed 32 31
Measure Type: Number
Unit of Measure: participants
18 18
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram Cognitive Behavioral Therapy
Hide Arm/Group Description escitalopram : Participants will receive treatment with escitalopram for 12 weeks. Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
All-Cause Mortality
Escitalopram Cognitive Behavioral Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram Cognitive Behavioral Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      0/40 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Escitalopram Cognitive Behavioral Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/42 (78.57%)      21/40 (52.50%)    
Gastrointestinal disorders     
diarrhea *  5/42 (11.90%)  5 2/40 (5.00%)  2
indigestion *  4/42 (9.52%)  4 2/40 (5.00%)  2
stomach cramps *  0/42 (0.00%)  0 2/40 (5.00%)  2
constipation *  5/42 (11.90%)  5 0/40 (0.00%)  0
General disorders     
fatigue *  5/42 (11.90%)  5 2/40 (5.00%)  2
dizziness *  5/42 (11.90%)  5 0/40 (0.00%)  0
dry mouth *  3/42 (7.14%)  3 0/40 (0.00%)  0
headache *  14/42 (33.33%)  14 4/40 (10.00%)  4
nausea *  10/42 (23.81%)  10 4/40 (10.00%)  4
insomnia *  7/42 (16.67%)  7 0/40 (0.00%)  0
decreased libido *  6/42 (14.29%)  6 0/40 (0.00%)  0
sedation *  11/42 (26.19%)  11 0/40 (0.00%)  0
Infections and infestations     
flu *  3/42 (7.14%)  3 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
upper respiratory infection *  4/42 (9.52%)  4 9/40 (22.50%)  9
Skin and subcutaneous tissue disorders     
rash *  0/42 (0.00%)  0 4/40 (10.00%)  4
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Helen Mayberg, MD
Organization: Emory University School of Medicine
Phone: 404-727-6740
EMail: hmayber@emory.edu
Layout table for additonal information
Responsible Party: Helen Mayberg, Emory University
ClinicalTrials.gov Identifier: NCT00367341     History of Changes
Other Study ID Numbers: IRB00026176
First Submitted: August 18, 2006
First Posted: August 22, 2006
Results First Submitted: November 21, 2013
Results First Posted: January 9, 2014
Last Update Posted: January 9, 2014