Combining Medications to Enhance Depression Outcomes (CO-MED)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00590863|
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : April 23, 2014
Last Update Posted : April 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: SSRI + placebo Drug: Escitalopram + Bupropion SR Drug: Venlafaxine XR + Mirtazapine||Phase 4|
The overall aim of Combining Medications to Enhance Depression Outcomes (CO-MED) is to enhance remission rates for outpatients with chronic or recurrent nonpsychotic major depressive disorder (MDD) as defined by DSM-IV TR, treated in primary or psychiatric care settings.
Current evidence indicates that remission, the goal of treatment, is found in only about one-third of representative depressed outpatients treated for up to 14 weeks with an initial SSRI. In addition, even for those who do respond or remit, over one-third relapse in the subsequent 12 months. Combinations of antidepressants are used in practice at the second or subsequent steps when relapse occurs in the longer term, or, in some cases, even acutely as a first step when speed of effect is a clinical priority. Whether such combinations could potentially offer higher remission rates, lower attrition, or greater longer-term benefit if used as initial treatments as compared to monotherapy remains to be examined.
CO-MED will test whether two different medications when given in combination as the first treatment step, compared to one medication, will enhance remission rates, increase speed of remission, be tolerable, and provide better sustained benefits in the longer term. Results of this study will inform practitioners in managing the treatment of patients with chronic or recurrent MDD.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||665 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Combining Medications to Enhance Depression Outcomes|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Active Comparator: SSRI + placebo
Participants will take escitalopram plus placebo.
Drug: SSRI + 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.
Active Comparator: Escitalopram + Bupropion SR
Participants will take escitalopram + bupropion-SR.
Drug: Escitalopram + Bupropion SR
Participant will take 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.
Active Comparator: Venlafaxine XR + Mirtazapine
Participants will take venlafaxine-XR + mirtazapine.
Drug: Venlafaxine XR + Mirtazapine
Participants will take 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.
- Quick Inventory of Depressive Symptoms [ Time Frame: Measured at Month 7 ]Percentage of patients that achieve remission, as defined as QIDS total score below 6 for last 2 study visits. QIDS depression scores range from 0 (normal) to 27 (very severe).
- Quality of Life Inventory [ Time Frame: Measured at Month 7 ]The Quality of Life Inventory (QOLI) is a 32-item comprehensive self-report of satisfaction in 16 areas of life, such as love, work, and health. Each area is rated in terms of satisfaction and the relationship of that area to overall quality of life. It yields an overall raw score and satisfaction ratings for the 16 individual areas of life. The QOLI raw score is an average of weighted satisfaction ratings computed only over areas of life judged to be Important or Extremely Important to the respondent. Higher scores indicate higher reported quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590863
|United States, Alabama|
|Tuscalossa VA Mental Health Clinic|
|Tuscaloosa, Alabama, United States, 35404|
|United States, California|
|Harbor UCLA Family Health Care Center|
|Harbor City, California, United States, 90710|
|UCLA Internal Medicine Clinic|
|Los Angeles, California, United States, 90024|
|Veterans Affairs Medical Center/FIRM Primary Care Clinic|
|San Diego, California, United States, 92161|
|United States, Illinois|
|Northwestern Psychiatric Outpatient Treatment Care Center|
|Chicago, Illinois, United States, 60611|
|United States, Kansas|
|Clinical Research Institute|
|Wichita, Kansas, United States, 67214|
|United States, Massachusetts|
|MGH/Northshore Medical Center (Salem Psychiatric Facility)|
|Salem, Massachusetts, United States, 01970|
|United States, Michigan|
|General Psychiatric Ambulatory Clinic|
|Ann Arbor, Michigan, United States, 48105|
|United States, New York|
|Irving Goldman Primary Care at North Shore Hospital|
|New York, New York, United States, 11040|
|United States, North Carolina|
|UNC Chapel Hill Adult Diagnostic & Treatment Clinic|
|Chapel Hill, North Carolina, United States, 27599-7160|
|United States, Oklahoma|
|Laureate Psychiatric Clinic and Hospital|
|Tulsa, Oklahoma, United States, 74135|
|United States, Pennsylvania|
|Bellefield Clinic of WPIC|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Tennessee|
|Vine Hill Community Clinic|
|Nashville, Tennessee, United States, 37212|
|United States, Texas|
|UT Southwestern Family Medicine Clinic|
|Dallas, Texas, United States, 75390|
|United States, Virginia|
|VCU Outpatient Psychiatry Clinic|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Madhukar H. Trivedi, MD||University of Texas Southwestern Medical Center|
|Study Director:||Stephen R. Wisniewski, PhD||University of Pittsburgh|
|Study Director:||Diane Warden, PhD, MBA||University of Texas Southwestern Medical Center|
|Study Director:||Kathy Shores-Wilson, PhD||University of Texas Southwestern Medical Center|
|Study Director:||David W. Morris, PhD||University of Texas Southwestern Medical Center|