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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  
Number of Participants  
[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  
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 [2]
[units: participants]
       
One     59     51     67     177  
Two     20     26     17     63  
Three or more     33     38     28     99  
None     2     0     3     5  
Chronic Episode of Depression (2 or More Years) [3]
[units: participants]
       
Yes     31     37     38     106  
No     83     78     77     238  
History of Suicide Attempt [4]
[units: participants]
       
Yes     4     13     8     25  
No     110     102     107     319  
[1] The race of participants was categorized as "Caucasian", "Black", and "Other".
[2] The number of participants who have had 1, 2, or 3 or more prior episodes of depression
[3] The number of participants who are experiencing a chronic episode of depression (2 or more years in duration).
[4] The number of participants who have a prior history of suicide attempt.



  Outcome Measures
  Show All Outcome Measures

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