Are Two Antidepressants a Good Initial Treatment for Depression?

New York State Psychiatric Institute

Status and phase: Completed; Phase 4

Conditions: Major Depression; Depression NOS; Dysthymia

Treatments: Drug: escitalopram + bupropion

Study type: Interventional

Funder types: Other

Identifiers

NCT00296712

#4653

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

escitalopram + bupropion

Experimental group

Description:

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

Treatment:

Drug: escitalopram + bupropion