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Are Two Antidepressants a Good Initial Treatment for Depression?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00296712
First received: February 24, 2006
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Major Depression
Dysthymia
Depression NOS
Drug: escitalopram + bupropion
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication.

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Hamilton Depression Scale (HAM-D) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Beck Depression Inventory (BDI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression Scale (CGI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression Scale (PGI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Arizona Sexual Experience Scale (ASEX) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: February 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296712

Locations
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
Investigators
Principal Investigator: Jonathan W. Stewart, MD. New York State Psychiatric Institute - Columbia University Department of Psychiatry
  More Information

Additional Information:
No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00296712     History of Changes
Other Study ID Numbers: #4653
Study First Received: February 24, 2006
Last Updated: April 26, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Bupropion
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014