Are Two Antidepressants a Good Initial Treatment for Depression?

April 26, 2012 updated by: New York State Psychiatric Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
same dosing as for monotherapy arms
Other Names:
  • escitalopram = Lexapro
  • bupropion = Wellbutrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Depression Scale (HAM-D)
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Beck Depression Inventory (BDI)
Time Frame: 10 weeks
10 weeks
Clinical Global Impression Scale (CGI)
Time Frame: 10 weeks
10 weeks
Patient Global Impression Scale (PGI)
Time Frame: 10 weeks
10 weeks
Arizona Sexual Experience Scale (ASEX)
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

February 24, 2006

First Submitted That Met QC Criteria

February 24, 2006

First Posted (Estimate)

February 27, 2006

Study Record Updates

Last Update Posted (Estimate)

April 27, 2012

Last Update Submitted That Met QC Criteria

April 26, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #4653

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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