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Are Two Antidepressants a Good Initial Treatment for Depression?

This study has been completed.

Sponsored by: New York State Psychiatric Institute
Information provided by: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00296712
  Purpose

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


Condition Intervention Phase
Major Depression
Dysthymia
Depression NOS
Drug: Escitalopram
Drug: Bupropion
Phase IV

MedlinePlus related topics:   Antidepressants    Depression   

Drug Information available for:   Escitalopram    Benzetimide    Citalopram    Citalopram hydrobromide    Dexetimide    Escitalopram oxalate    Bupropion hydrochloride    Bupropion   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication.

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
Primary Completion Date:   July 2006 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Escitalopram
    Day 1-4: 10 mg; day 1-5: 20 mg; day 9-12: 30 mg; day 13-56: 40 mg.
    Drug: Bupropion
    day 1-4: 150 mg; day 5-8: 300 mg; day 9-12: 300 mg; day 13-56: 450 mg.
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)
  Contacts and Locations

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


Depression Evaluation Service - official website  This link exits the ClinicalTrials.gov site
 
New York State Psychiatric Institute - official website  This link exits the ClinicalTrials.gov site
 

Responsible Party:   New York State Psychiatric Institute ( Jonathon W. Stewart, M.D. )
Study ID Numbers:   IRB4653
First Received:   February 24, 2006
Last Updated:   January 14, 2008
ClinicalTrials.gov Identifier:   NCT00296712
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

Study placed in the following topic categories:
Dopamine
Depression
Mental Disorders
Bupropion
Mood Disorders
Dysthymic Disorder
Depressive Disorder, Major
Dexetimide
Depressive Disorder
Citalopram
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 30, 2008




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