Trial record 1 of 2 for:
CO-MED NIMH
Combining Medications to Enhance Depression Outcomes (CO-MED)
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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 |
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Recruitment Status :
Completed
First Posted : January 11, 2008
Results First Posted : April 23, 2014
Last Update Posted : April 23, 2014
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Sponsor:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
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Brief Summary:
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 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
MedlinePlus related topics:
Medicines
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: SSRI + placebo
Participants will take escitalopram plus placebo.
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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.
Other Names:
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Active Comparator: Escitalopram + Bupropion SR
Participants will take escitalopram + bupropion-SR.
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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.
Other Names:
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Active Comparator: Venlafaxine XR + Mirtazapine
Participants will take venlafaxine-XR + mirtazapine.
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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.
Other Names:
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Primary Outcome Measures :
- 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).
Secondary Outcome Measures :
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Seeking treatment at the primary or specialty care site, and be planning to continue living in the area of that clinic for the duration of the study
- Meets clinical criteria for nonpsychotic MDD, recurrent (with the current episode being at least 2 months in duration), or chronic (current episode greater than 2 years) as defined by a clinical interview and confirmed by the MINI International Neuropsychiatric Interview (MINI)
- Screening 17 item HRSD score of 16 or greater
- Treatment with antidepressant medication combinations is clinically acceptable
- Patient with and without current suicidal ideation may be included in the study as long as outpatient treatment is clinically appropriate
Exclusion Criteria:
- Pregnant or breastfeeding
- Plans to become pregnant over the ensuing 8 months following study entry or are sexually active and not using adequate birth control
- History (lifetime) of psychotic depression, schizophrenia, bipolar (I, II, or NOS), schizoaffective, or other Axis I psychotic disorders
- Current psychotic symptom(s)
- History (within the last 2 years before study entry) of anorexia or bulimia
- Current primary diagnosis of obsessive compulsive disorder
- Current substance dependence that requires inpatient detoxification or inpatient treatment
- Requiring immediate hospitalization for a psychiatric disorder
- Definite history of intolerance or allergy (lifetime) to any protocol medication
- History of clear nonresponse to an adequate trial of an FDA-approved monotherapy in the current MDE if recurrent, or during the last 2 years before study entry if chronic
- History of clear nonresponse to an adequate trial of any study medication used as a monotherapy, or to one or more of the protocol combinations in the current or any prior MDE
- Currently taking any of the study medications at any dose
- Having taken Prozac (fluoxetine) or an MAOI in the 4 weeks before study entry
- Presence of an unstable general medical condition (GMC) that will likely require hospitalization or to be deemed terminal (life expectancy less than 6 months after study entry)
- Currently taking medications or have GMCs that contraindicate any study medications (e.g., seizure disorder)
- Requiring medications for GMCs that contraindicate any study medication
- Epilepsy or other conditions requiring an anticonvulsant
- Lifetime history of having a seizure including febrile or withdrawal seizures
- Receiving or have received vagus nerve stimulation (VNS), electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or other somatic antidepressant treatments
- Currently taking or having taken within the 7 days before study entry any of the following exclusionary medications: antipsychotic medications, anticonvulsant medications, mood stabilizers, or central nervous system stimulants (antidepressant medication used for the treatment of depression or other purposes such as smoking cessation or pain are excluded since these agents may interfere with the testing of the major hypotheses under study)
- Uncontrolled narrow angle glaucoma
- Taking thyroid medication for hypothyroidism may be included only if stable on the medication for 3 months
- Using agents within the 7 days before study entry that are potential augmenting agents (e.g., T3 in the absence of thyroid disease, SAMe, St. John's Wort, lithium, buspirone)
- Therapy that is depression-specific
Information from the National Library of Medicine
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
Locations
| 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 | |
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
| 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 |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00590863 |
| Other Study ID Numbers: |
N01 MH090003-02 DSIR AT ( Registry Identifier: NCT00590863 ) |
| First Posted: | January 11, 2008 Key Record Dates |
| Results First Posted: | April 23, 2014 |
| Last Update Posted: | April 23, 2014 |
| Last Verified: | April 2009 |
Keywords provided by National Institute of Mental Health (NIMH):
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depression, medication, antidepressant, chronic, recurrent |
Additional relevant MeSH terms:
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Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Dexetimide Mirtazapine Citalopram Bupropion Venlafaxine Hydrochloride Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Dopamine Uptake Inhibitors |