Combining Medications to Enhance Depression Outcomes
Overview
- Phase
- Phase 4
- Intervention
- SSRI + placebo
- Conditions
- Major Depressive Disorder
- Sponsor
- National Institute of Mental Health (NIMH)
- Enrollment
- 665
- Locations
- 15
- Primary Endpoint
- Quick Inventory of Depressive Symptoms
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Detailed Description
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.
Investigators
Eligibility 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
Arms & Interventions
SSRI + placebo
Participants will take escitalopram plus placebo.
Intervention: SSRI + placebo
Escitalopram + Bupropion SR
Participants will take escitalopram + bupropion-SR.
Intervention: Escitalopram + Bupropion SR
Venlafaxine XR + Mirtazapine
Participants will take venlafaxine-XR + mirtazapine.
Intervention: Venlafaxine XR + Mirtazapine
Outcomes
Primary Outcomes
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 Outcomes
- Quality of Life Inventory(Measured at Month 7)