Does Dual Therapy Hasten Antidepressant Response?
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: escitalopram; bupropion extra long (XL); escitalopram + bupropion
Intervention description: 10mg/d increasing by 10 mg/week to a maximum of 40 mg/d if tolerated and not remitted; 150mg/d increasing to 300 mg/d after 1 week and 450 mg/d after 3 weeks, all increases if tolerated and not remitted; same dosing schedule as for monotherapy
Intervention MeSH terms: Dexetimide; Citalopram; Bupropion; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: depression; Major Depressive Disorder

Summary:

      This study will utilize a randomized double-blind design to evaluate whether initial
      treatment with two anti-depressant medications (escitalopram and bupropion) results in more
      rapid remission and greater over-all remission rates than either monotherapy in 240 depressed
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women ages 18-65

          2. Major Depressive Disorder as primary diagnosis

          3. Physically healthy

          4. Signs informed consent

          5. Montgomery Asberg Depression Rating Scale (MADRS) >= 22

        Exclusion Criteria:

          1. Bipolar Disorder (ie, Bipolar I, Bipolar II, Bipolar NOS)

          2. Life-time history of psychosis

          3. Current (ie, last 6 months) drug or alcohol abuse or dependence (except nicotine)

          4. Currently taking effective antidepressant medication

          5. Prior adequate treatment in current depressive episode with a selective serotonin
             re-uptake inhibitor (SSRI), bupropion (BUP) or bupropion (BUP) + a selective serotonin
             re-uptake inhibitor (SSRI) ("adequate" is defined as >= 4 weeks taking >= 2/3
             Physician's Desk Reference (PDR) maximal dose

          6. Most recent antidepressant was within 5 weeks for fluoxetine and 1 week for all others

          7. Currently taking a medication contraindicated with either study medication

          8. Life time history of anorexia or bulimia

          9. Life time history of seizure or known increased seizure risk (e.g., history of
             significant brain trauma, taking pro-convulsant medication, known anatomical brain
             lesion)

         10. Currently taking psychoactive medication deemed to be necessary (including but not
             limited anticonvulsants, antidepressants, antipsychotics, steroids, and B-blockers);
             occasional use of hypnotics (ie, less than three times per week) will be allowed

         11. Unstable medical condition (ie, condition not adequately stabilized for >= 3 months)

         12. Prior intolerance to escitalopram (ESC) or bupropion (BUP)

         13. Inadequate understanding of English (for US site; Canadian site permits French
             fluency)

         14. Currently pregnant or breast-feeding; fecund women not using adequate contraceptive
             methods