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Identifying Factors That Predict Antidepressant Treatment Response

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Helen Mayberg, Emory University
ClinicalTrials.gov Identifier:
NCT00360399
First received: August 2, 2006
Last updated: July 27, 2016
Last verified: July 2016
Results First Received: June 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Interventions: Drug: Escitalopram
Drug: Duloxetine
Behavioral: Cognitive behavioral therapy (CBT)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited through the Emory University Mood and Anxiety Disorders Program. Men and women, aged 18-65, meeting DSM-IV criteria for a current major depressive disorder, and who had not received prior treatment for a mood disorder were eligible. 515 consented to participate in the trial and 344 were randomized to a treatment arm.

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

A total of 344 participants were randomized as follows:

114 randomized to the Escitalopram arm 115 randomized to the Duloxetine arm 115 randomized to the Cognitive behavioral therapy (CBT) arm

28 participants did not return for a post-randomization assessment, resulting in 316 participants with data to analyze.


Reporting Groups
  Description
Escitalopram Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
Duloxetine Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
Cognitive Behavioral Therapy (CBT) Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks

Participant Flow:   Overall Study
    Escitalopram   Duloxetine   Cognitive Behavioral Therapy (CBT)
STARTED   114   115   115 
Had Post-randomization Assessment   105   106   105 
COMPLETED   86   79   69 
NOT COMPLETED   28   36   46 



  Baseline Characteristics
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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.
Participants who consented to participate in the trial and who were randomized to a treatment arm.

Reporting Groups
  Description
Escitalopram Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
Duloxetine Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
Cognitive Behavioral Therapy (CBT) Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
Total Total of all reporting groups

Baseline Measures
   Escitalopram   Duloxetine   Cognitive Behavioral Therapy (CBT)   Total 
Overall Participants Analyzed 
[Units: Participants]
 114   115   115   344 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   114   115   115   344 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.6  (12.1)   38.3  (11.4)   40.0  (11.3)   40.0  (11.7) 
Gender 
[Units: Participants]
       
Female   64   68   64   196 
Male   50   47   51   148 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   36   34   32   102 
Not Hispanic or Latino   78   81   83   242 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) [1] 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   28   23   13   64 
White   47   56   61   164 
More than one race   0   0   0   0 
Unknown or Not Reported   39   36   41   116 
[1] The race of participants was categorized as "Caucasian", "Black", and "Other".
Region of Enrollment 
[Units: Participants]
       
United States   114   115   115   344 
Current Anxiety Disorder 
[Units: Participants]
       
Yes   67   67   71   205 
No   47   48   44   139 
Previous Episode(s) of Depression [1] 
[Units: Participants]
       
One   59   51   67   177 
Two   20   26   17   63 
Three or more   33   38   28   99 
None   2   0   3   5 
[1] The number of participants who have had 1, 2, or 3 or more prior episodes of depression
Chronic Episode of Depression (2 or More Years) [1] 
[Units: Participants]
       
Yes   31   37   38   106 
No   83   78   77   238 
[1] The number of participants who are experiencing a chronic episode of depression (2 or more years in duration).
History of Suicide Attempt [1] 
[Units: Participants]
       
Yes   4   13   8   25 
No   110   102   107   319 
[1] The number of participants who have a prior history of suicide attempt.


  Outcome Measures
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1.  Primary:   Remission From Major Depressive Episode in Intent to Treat Sample   [ Time Frame: Up to 12 Weeks ]

2.  Primary:   Remission From Major Depressive Episode Among Participants Who Completed the Intervention   [ Time Frame: Measured at Weeks 10 and 12 ]

3.  Secondary:   Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample   [ Time Frame: Up to 12 Weeks ]

4.  Secondary:   Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention   [ Time Frame: Measured at Weeks 10 and 12 ]

5.  Secondary:   Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment   [ Time Frame: Measured at 6, 9, 12, 15, 18, 21, and 24 months ]

6.  Secondary:   Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy   [ Time Frame: Measured after 12 weeks of combined treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Helen Mayberg
Organization: Emory University
phone: 404-727-6740
e-mail: hmayber@emory.edu


Publications:

Responsible Party: Helen Mayberg, Emory University
ClinicalTrials.gov Identifier: NCT00360399     History of Changes
Other Study ID Numbers: IRB00024975
P50MH077083 ( US NIH Grant/Contract Award Number )
Study First Received: August 2, 2006
Results First Received: June 16, 2016
Last Updated: July 27, 2016
Health Authority: United States: Federal Government