Are Two Antidepressants a Good Initial Treatment for Depression?

Major Depression Clinical Trial

Official title:

Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00296712
• Other study ID #: #4653
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2006
• Last updated: April 26, 2012
• Start date: February 2005
• Est. completion date: July 2006

Study information

• Verified date: April 2012
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression NOS
• Depressive Disorder
• Depressive Disorder, Major
• Dysthymia
• Major Depression

Intervention

Drug:
• escitalopram + bupropion
same dosing as for monotherapy arms

Locations

Country	Name	City	State
United States	Depression Evaluation Service - New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale (HAM-D)		10 weeks	No
Secondary	Beck Depression Inventory (BDI)		10 weeks	No
Secondary	Clinical Global Impression Scale (CGI)		10 weeks	No
Secondary	Patient Global Impression Scale (PGI)		10 weeks	No
Secondary	Arizona Sexual Experience Scale (ASEX)		10 weeks	No

External Links

•   Depression Evaluation Service - official website
•   New York State Psychiatric Institute - official website