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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00590863 |
This study will compare whether a combination of antidepressant medications is better than one antidepressant medication alone when given as initial treatment for people with chronic or recurrent major depressive disorder.
Condition | Intervention | Phase |
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Major Depressive Disorder |
Drug: One of the following: bupropion, escitalopram, mirtazapine, or venlafaxine Drug: Two of the following: bupropion, escitalopram, mirtazapine or venlafaxine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Combining Medications to Enhance Depression Outcomes |
Estimated Enrollment: | 660 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Participants will take one antidepressant medication plus placebo.
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Drug: One of the following: bupropion, escitalopram, mirtazapine, or venlafaxine
In addition to receiving daily, oral antidepressant medication, participants will also receive daily, oral placebo for up to 28 weeks.
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B: Experimental
Participants will take a combination of two antidepressant medications.
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Drug: Two of the following: bupropion, escitalopram, mirtazapine or venlafaxine
Participants will receive daily, oral antidepressant medication combination for up to 28 weeks.
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Diane Stegman, RN | 214-648-4622 | diane.stegman@utsouthwestern.edu |
United States, Alabama | |
Tuscalossa VA Mental Health Clinic | Recruiting |
Tuscaloosa, Alabama, United States, 35404 | |
Contact: Colleen Beall, DrPH 205-554-2000 ext 2575 colleen.beall2@va.gov | |
Contact: Beverly Whitfield, M.A. 205-554-2000 ext 2733 beverly.whitfield@va.gov | |
Principal Investigator: Lori Davis, MD | |
United States, California | |
Harbor UCLA Family Health Care Center | Recruiting |
Harbor City, California, United States, 90710 | |
Contact: Marcy Epstein, MSN 310-222-7957 mepstein@labiomed.org | |
Contact: Aurora Rosales, MA 310-534-6296 arosales@labiomed.org | |
Principal Investigator: Ira Lesser, MD | |
UCLA Internal Medicine Clinic | Recruiting |
Los Angeles, California, United States, 90024 | |
Contact: Michelle Abrams, RN 310-825-0797 mabrams@qeeg.npi.ucla.edu | |
Contact: Sarah Rowe, BS 310-825-1330 sarah@qeeg.npi.ucla.edu | |
Principal Investigator: Andrew Leuchter, MD | |
Veterans Affairs Medical Center/FIRM Primary Care Clinic | Recruiting |
San Diego, California, United States, 92161 | |
Contact: Ellen Solorzano, M.A. 619-725-3583 pumakat@earthlink.net | |
Principal Investigator: Sid Zisook, MD | |
United States, Illinois | |
Northwestern Psychiatric Outpatient Treatment Care Center | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Jenelle Fleck, MN, RN, CNP 312-695-6929 j-fleck2@northwestern.edu | |
Contact: Monya Meinel, BA 312-695-2065 m-meinel@northwestern.edu | |
Principal Investigator: William Gilmer, MD | |
United States, Kansas | |
Clinical Research Institute | Recruiting |
Wichita, Kansas, United States, 67214 | |
Contact: Diane Hilger, LPN 316-293-1812 dhilger@cri-research.net | |
Contact: Kelli Omo, RN, BSN 316-293-1821 komo@cri-research.net | |
Principal Investigator: Sheldon Preskorn, MD | |
United States, Massachusetts | |
MGH/Northshore Medical Center (Salem Psychiatric Facility) | Recruiting |
Salem, Massachusetts, United States, 01970 | |
Contact: Amy Farabaugh, PhD 617-726-1629 afarabaugh@partners.org | |
Contact: Michele Candrian, MS 617-726-4686 mcandrian@partners.org | |
Principal Investigator: Maurizio Fava, MD | |
Principal Investigator: Andrew Nierenberg, MD | |
United States, Michigan | |
General Psychiatric Ambulatory Clinic | Recruiting |
Ann Arbor, Michigan, United States, 48105 | |
Contact: Kate Bullard, MSW, MPH 734-763-4904 krharris@med.umich.edu | |
Principal Investigator: Elizabeth Young, MD | |
United States, New York | |
Irving Goldman Primary Care at North Shore Hospital | Recruiting |
New York, New York, United States, 11040 | |
Contact: Donna O'Shea, MS 212-543-6523 osheado@pi.cpmc.columbia.edu | |
Principal Investigator: Patrick McGrath, MD | |
United States, North Carolina | |
UNC Chapel Hill Adult Diagnostic & Treatment Clinic | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7160 | |
Contact: Joanne DeVeaugh-Giess, MA, LPA 919-843-7081 joannedv@med.unc.edu | |
Contact: Brenda Pearson, LCSW 919-843-8084 bpearson@med.unc.edu | |
Principal Investigator: Bradley Gaynes, MD, MPH | |
United States, Oklahoma | |
Laureate Psychiatric Clinic and Hospital | Recruiting |
Tulsa, Oklahoma, United States, 74135 | |
Contact: Bob Williams, MS, RN, CCRC 918-481-4090 rawilliams@saintfrancis.com | |
Contact: Debbie Hale, RN 918-491-3718 dbhale@saintfrancis.com | |
Principal Investigator: Jeff Mitchell, MD | |
United States, Pennsylvania | |
Bellefield Clinic of WPIC | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Crystal Spotts, MEd 412-246-5764 spottscr@msx.upmc.edu | |
Contact: Luann Shutt, RN, MSN 412-246-5762 shuttls@msx.upmc.edu | |
Principal Investigator: Edward Friedman, MD | |
United States, Tennessee | |
Vine Hill Community Clinic | Recruiting |
Nashville, Tennessee, United States, 37212 | |
Contact: Tynya Patton, MA 615-322-0505 tynya.patton@vanderbilt.edu | |
Contact: Stephanie Addington, MA 615-343-1973 stephanie.addington@vanderbilt.edu | |
Principal Investigator: Richard Shelton, MD | |
United States, Texas | |
UT Southwestern Family Medicine Clinic | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: David Morris, PhD 214-648-0162 davidw.morris@utsouthwestern.edu | |
Contact: Aasia Ali, MBBS aasia.ali@utsouthwestern.edu | |
Principal Investigator: Mustafa Husain, MD | |
United States, Virginia | |
VCU Outpatient Psychiatry Clinic | Recruiting |
Richmond, Virginia, United States, 23298 | |
Contact: Megan Edwards, M.P.H., CHES 804-827-3033 mcedwards@vcu.edu | |
Principal Investigator: Susan Kornstein, MD |
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 |
Responsible Party: | University of Texas Southwestern Medical Center ( Madhukar H. Trivedi, MD ) |
Study ID Numbers: | N01 MH90003-02, DSIR AT |
Study First Received: | December 26, 2007 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00590863 |
Health Authority: | United States: Federal Government |
depression, medication, antidepressant, chronic, recurrent |
Depression Depressive Disorder, Major Depressive Disorder Mirtazapine Citalopram Recurrence Serotonin Histamine |
Behavioral Symptoms Dopamine Mental Disorders Bupropion Venlafaxine Mood Disorders Histamine phosphate Dexetimide |
Dopamine Uptake Inhibitors Parasympatholytics Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Adrenergic Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents Therapeutic Uses Antidepressive Agents, Second-Generation Antidepressive Agents |
Histamine Agents Adrenergic alpha-Antagonists Serotonin Uptake Inhibitors Pharmacologic Actions Antidepressive Agents, Tricyclic Muscarinic Antagonists Serotonin Agents Histamine Antagonists Autonomic Agents Histamine H1 Antagonists Dopamine Agents Adrenergic Antagonists Peripheral Nervous System Agents Central Nervous System Agents |