Does Dual Therapy Hasten Antidepressant Response?

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute of Mental Health (NIMH); University of Ottawa
• Treatments: Antidepressive Agents; Bupropion; Citalopram; Dexetimide

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