Clinical trial NCT00296712: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depression
Dysthymia
Depression NOS
Keywords: Major Depression
Dysthymia
Depression NOS
Escitalopram
Bupropion
Dual Therapy
Combination Therapy
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2006-02-27
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Depression Scale (HAM-D)
timeFrame: 10 weeks
Secondary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: 10 weeks
measure: Clinical Global Impression Scale (CGI)
timeFrame: 10 weeks
measure: Patient Global Impression Scale (PGI)
timeFrame: 10 weeks
measure: Arizona Sexual Experience Scale (ASEX)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Depression Evaluation Service - New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute - Columbia University Department of Psychiatry
name: Jonathan W. Stewart, MD.
role: PRINCIPAL_INVESTIGATOR
References:
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.