Status:
COMPLETED
Are Two Antidepressants a Good Initial Treatment for Depression?
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Major Depression
Dysthymia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- Currently depressed (DSM-IV Major Depression, Dysthymia or Depression NOS)
- HAMD-D (21-Item) \> 9
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00296712
Start Date
February 1 2005
End Date
July 1 2006
Last Update
April 27 2012
Active Locations (1)
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1
Depression Evaluation Service - New York State Psychiatric Institute
New York, New York, United States, 10032