Are Two Antidepressants a Good Initial Treatment for Depression? - Full Text View

Sponsor:	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

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.

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

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

U.S. FDA Resources

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:

Day 1-4: 10 mg; day 1-5: 20 mg; day 9-12: 30 mg; day 13-56: 40 mg.

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

Additional 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

No publications provided

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

Dopamine Uptake Inhibitors
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Depressive Disorder, Major
Cholinergic Agents
Mental Disorders
Therapeutic Uses
Dexetimide

Antidepressive Agents, Second-Generation
Antidepressive Agents
Depression
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Bupropion
Mood Disorders
Dopamine Agents
Dysthymic Disorder

ClinicalTrials.gov processed this record on November 27, 2009