Combining Medications to Enhance Depression Outcomes (CO-MED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00590863
First received: December 26, 2007
Last updated: April 21, 2014
Last verified: April 2009
Results First Received: November 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: SSRI + placebo
Drug: Escitalopram + Bupropion SR
Drug: Venlafaxine XR + Mirtazapine

  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 from March 2008 through April of 2009, with the last subject completing the study in September 2009. Participants were recruited from six primary care and nine psychiatric care sites within the NIMH Depression Trials Network.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Outpatient enrollees, 18-75 years old, met DSM-IV-TR criteria for either recurrent or chronic MDD. Eligible participants had to be in the index episode for at least two months and to score ≥16 on the 17-item HAM-D. Those with any history of psychotic illness or bipolar disorder, or in need of hospitalization were ineligible.

Reporting Groups
  Description
Escitalopram + Bupropion SR Participant takes Burpopion SR (150 to 450 mg/day)+ Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
Venlafaxine XR + Mirtazapine Participant takes Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
Escitalopram + Placebo Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.

Participant Flow:   Overall Study
    Escitalopram + Bupropion SR     Venlafaxine XR + Mirtazapine     Escitalopram + Placebo  
STARTED     221     220     224  
COMPLETED     137     138     146  
NOT COMPLETED     84     82     78  



  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.
Sociodemographic Characteristics

Reporting Groups
  Description
Escitalopram + Bupropion SR Participant takes Burpopion SR (150 to 450 mg/day)+ Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
Venlafaxine XR + Mirtazapine Participant takes Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
Escitalopram + Placebo Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
Total Total of all reporting groups

Baseline Measures
    Escitalopram + Bupropion SR     Venlafaxine XR + Mirtazapine     Escitalopram + Placebo     Total  
Number of Participants  
[units: participants]
  221     220     224     665  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     221     220     224     665  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  42.4  ± 13.5     42.0  ± 12.4     43.6  ± 13.1     42.7  ± 13.0  
Gender  
[units: participants]
       
Female     149     160     143     452  
Male     72     60     81     213  
Region of Enrollment  
[units: participants]
       
United States     221     220     224     665  



  Outcome Measures
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1.  Primary:   Quick Inventory of Depressive Symptoms   [ Time Frame: Measured at Month 7 ]

2.  Secondary:   Quality of Life Inventory   [ Time Frame: Measured at Month 7 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information
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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:  
Name/Title: Madhukar H. Trivedi, M.D.
Organization: Univeristy of Texas Southwestern Medical Center, Dallas
phone: 214-648-0188
e-mail: Madhukar.Trivedi@UTSouthwestern.edu


Publications of Results:
Publications automatically indexed to this study:


Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00590863     History of Changes
Other Study ID Numbers: N01 MH090003-02, DSIR AT
Study First Received: December 26, 2007
Results First Received: November 28, 2012
Last Updated: April 21, 2014
Health Authority: United States: Federal Government