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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 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

NCT ID

First Posted

February 24, 2006

Last Updated

April 26, 2012

Sponsor

New York State Psychiatric Institute

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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