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CompletedNCT00296712Updated Apr 27, 2012

Are Two Antidepressants a Good Initial Treatment for Depression?

A Phase 4 interventional study of escitalopram + bupropion in Major Depression, Dysthymia and Depression NOS, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-04-27.

Sponsored by New York State Psychiatric Institute · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Relatively drug naive patients will receive two antidepressant medications as initial treatment.

Read the detailed description

While antidepressant medications are often effective in relieving depressive symptoms, at least 60% of patients do not remit with the first agent tried. This pilot study will assess whether giving two standard medications simultaneously (i.e., Escitalopram and Bupropion) is both tolerated and improves response while decreasing drop outs. This is a replication of a previous study.

02

Conditions studied

  • Major Depression
  • Dysthymia
  • Depression NOS

Keywords

  • Major Depression
  • Dysthymia
  • Depression NOS
  • Escitalopram
  • Bupropion
  • Dual Therapy
  • Combination Therapy
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 55 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Currently depressed (DSM-IV Major Depression, Dysthymia or Depression NOS)
  • HAMD-D (21-Item) > 9

Exclusion criteria

Exclusion Criteria:

  • Prior ineffective adequate trial on either study medication ($ 4 weeks on either escitalopram >20 mg/d or bupropion >300 mg/d; >4 weeks on citalopram >40 mg/d)
  • History suggesting increased risk for Seizures (e.g., prior Seizure as an adult, diagnosed Seizure Disorder, taking medication known to increase seizure risk, history of significant head trauma, history of Bulimia or Anorexia)
  • History of intolerance to either study medication unless patient and M.D. agree side effect is probably manageable
  • Alcohol and/or drug abuse/dependence during past year
  • Major medical problems that are not well controlled (e.g., untreated hypertension or diabetes)
  • Bipolar I, Bipolar II
  • History of Psychosis, or current Psychosis
  • Currently taking antidepressants or mood stabilizers, which is judged unwise to discontinue (occasional sleep medication or benzodiazepine for Anxiety is allowed)
  • Not currently depressed (whether considered due to current treatment or not)
  • Active suicidal risk (history of suicide attempts will be evaluated on a case by case basis)
  • Pregnant or breast-feeding
  • Premenopausal women not using known effective birth control
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    escitalopram + bupropion

    patients begin on escitalopram 10 mg/d, then bupropion 150 mg/d is added and each is alternately increased as tolerated to maximal dose of escitalopram of 40 mg/d and of bupropion of 450 mg/d

    Drug: escitalopram + bupropion

Interventions

  • Drugescitalopram + bupropion

    same dosing as for monotherapy arms

    Also known as: escitalopram = Lexapro, bupropion = Wellbutrin

06

What researchers measure

Primary outcomes

  1. Hamilton Depression Scale (HAM-D)

    Time frame: 10 weeks

Secondary outcomes

  1. Beck Depression Inventory (BDI)

    Time frame: 10 weeks

  2. Clinical Global Impression Scale (CGI)

    Time frame: 10 weeks

  3. Patient Global Impression Scale (PGI)

    Time frame: 10 weeks

  4. Arizona Sexual Experience Scale (ASEX)

    Time frame: 10 weeks

07

Study locations

1 site
  • Depression Evaluation Service - New York State Psychiatric Institute
    New York, New York 10032, United States
08

References and documents

Publications

  • Stewart JW, McGrath PJ, Deliyannides RA, Quitkin FM. Does dual antidepressant therapy as initial treatment hasten and increase remission from depression? J Psychiatr Pract. 2009 Sep;15(5):337-45. doi: 10.1097/01.pra.0000361276.88339.44. PubMed 19820552 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00296712
Lead sponsor
New York State Psychiatric Institute
Responsible party
Sponsor
First posted
Feb 27, 2006
Start date
Feb 2005
Primary completion
Jul 2006
Completion
Jul 2006
Last update
Apr 27, 2012

Study contacts

Jonathan W. Stewart, MD.
principal investigator · New York State Psychiatric Institute - Columbia University Department of Psychiatry

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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