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Are Two Antidepressants a Good Initial Treatment for Depression?

Primary Purpose

Major Depression, Dysthymia, Depression NOS

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
escitalopram + bupropion
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Major Depression, Dysthymia, Depression NOS, Escitalopram, Bupropion, Dual Therapy, Combination Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Depression Evaluation Service - New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

escitalopram + bupropion

Arm 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

Outcomes

Primary Outcome Measures

Hamilton Depression Scale (HAM-D)

Secondary Outcome Measures

Beck Depression Inventory (BDI)
Clinical Global Impression Scale (CGI)
Patient Global Impression Scale (PGI)
Arizona Sexual Experience Scale (ASEX)

Full Information

First Posted
February 24, 2006
Last Updated
April 26, 2012
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00296712
Brief Title
Are Two Antidepressants a Good Initial Treatment for Depression?
Official Title
Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Dysthymia, Depression NOS
Keywords
Major Depression, Dysthymia, Depression NOS, Escitalopram, Bupropion, Dual Therapy, Combination Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
escitalopram + bupropion
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
escitalopram + bupropion
Other Intervention Name(s)
escitalopram = Lexapro, bupropion = Wellbutrin
Intervention Description
same dosing as for monotherapy arms
Primary Outcome Measure Information:
Title
Hamilton Depression Scale (HAM-D)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI)
Time Frame
10 weeks
Title
Clinical Global Impression Scale (CGI)
Time Frame
10 weeks
Title
Patient Global Impression Scale (PGI)
Time Frame
10 weeks
Title
Arizona Sexual Experience Scale (ASEX)
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan W. Stewart, MD.
Organizational Affiliation
New York State Psychiatric Institute - Columbia University Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depression Evaluation Service - New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19820552
Citation
Stewart JW, McGrath PJ, Deliyannides RA, Quitkin FM. Does dual antidepressant therapy as initial treatment hasten and increase remission from depression? J Psychiatr Pract. 2009 Sep;15(5):337-45. doi: 10.1097/01.pra.0000361276.88339.44.
Results Reference
derived
Links:
URL
http://www.depression-nyc.org
Description
Depression Evaluation Service - official website
URL
http://www.nyspi.org
Description
New York State Psychiatric Institute - official website

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Are Two Antidepressants a Good Initial Treatment for Depression?

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