Combining Medications to Enhance Depression Outcomes
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): SSRI + placebo; Escitalopram + Bupropion SR; Venlafaxine XR + Mirtazapine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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 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.; 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 intervention name(s): escitalopram; placebo; escitalopram; bupropion-SR; venlafaxine-XR; mirtazapine
Intervention MeSH terms: Dexetimide; Mirtazapine; Citalopram; Bupropion; Venlafaxine Hydrochloride; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: depression, medication, antidepressant, chronic, recurrent