Are Two Antidepressants a Good Initial Treatment for Depression?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2006-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Major Depression Dysthymia Depression NOS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

escitalopram + bupropion

Intervention Type DRUG

same dosing as for monotherapy arms

Interventions

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escitalopram + bupropion

same dosing as for monotherapy arms

Intervention Type DRUG

Other Intervention Names

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escitalopram = Lexapro bupropion = Wellbutrin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No