Are Two Antidepressants a Good Initial Treatment for Depression?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00296712
Recruitment Status : Completed
First Posted : February 27, 2006
Last Update Posted : April 27, 2012
Information provided by (Responsible Party):
New York State Psychiatric Institute

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

Condition or disease Intervention/treatment Phase
Major Depression Dysthymia Depression NOS Drug: escitalopram + bupropion Phase 4

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  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication.
Study Start Date : February 2005
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

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

Primary Outcome Measures :
  1. Hamilton Depression Scale (HAM-D) [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00296712

United States, New York
Depression Evaluation Service - New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Principal Investigator: Jonathan W. Stewart, MD. New York State Psychiatric Institute - Columbia University Department of Psychiatry

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: New York State Psychiatric Institute Identifier: NCT00296712     History of Changes
Other Study ID Numbers: #4653
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012

Keywords provided by New York State Psychiatric Institute:
Major Depression
Depression NOS
Dual Therapy
Combination Therapy

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Dysthymic Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents