Are Two Antidepressants a Good Initial Treatment for Depression?

Phase 4

Completed

• Conditions: Major Depression; Dysthymia; Depression NOS
• Interventions: Drug: escitalopram + bupropion

• Registration Number: NCT00296712
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2006-02-24
• Study First Submitted QC: 2006-02-24
• Study First Posted: 2006-02-27
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-26
• Last Update Posted: 2012-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
escitalopram + bupropion	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

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Scale (HAM-D)	10 weeks

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory (BDI)	10 weeks
Clinical Global Impression Scale (CGI)	10 weeks
Patient Global Impression Scale (PGI)	10 weeks
Arizona Sexual Experience Scale (ASEX)	10 weeks

Trial Locations

Locations (1)

Depression Evaluation Service - New York State Psychiatric Institute; 🇺🇸 New York, New York, United States