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OpenTrials
Completed

NCT Number: NCT00296712

Are Two Antidepressants a Good Initial Treatment for Depression?

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Depression Evaluation Service - New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

escitalopram + bupropion

Drug

same dosing as for monotherapy arms

Other names: escitalopram = Lexapro, bupropion = Wellbutrin

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

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Official study title

Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication.

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Feb 27, 2006
Registry last updated
Apr 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.