Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Imaging Predictors of Treatment Response in Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Helen Mayberg, Emory University
ClinicalTrials.gov Identifier:
NCT00367341
First received: August 18, 2006
Last updated: November 21, 2013
Last verified: November 2013
Results First Received: November 21, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: escitalopram
Behavioral: Cognitive Behavioral Therapy (CBT)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Participant Flow:   Overall Study
    Escitalopram     Cognitive Behavioral Therapy  
STARTED     42     40  
COMPLETED     40     40  
NOT COMPLETED     2     0  
Physician Decision                 1                 0  
Protocol Violation                 1                 0  



  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  
Number of Participants  
[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
  Hide 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 ]

Measure Type Primary
Measure Title Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks
Measure Description # of study participants with Hamilton Depression-17-item score less than or equal to 7.
Time Frame Measured at week 12  
Safety Issue No  

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.
completed study participants in 12-week-trial

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.

Measured Values
    Escitalopram     Cognitive Behavioral Therapy  
Number of Participants Analyzed  
[units: participants]
  32     31  
Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks  
[units: participants]
  12     12  

No statistical analysis provided for Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks



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

Measure Type Secondary
Measure Title Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks
Measure 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.  
Safety Issue No  

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.
completers

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.

Measured Values
    Escitalopram     Cognitive Behavioral Therapy  
Number of Participants Analyzed  
[units: participants]
  32     31  
Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks  
[units: participants]
  18     18  

No statistical analysis provided for Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information