Are Two Antidepressants a Good Initial Treatment for Depression?
Information source: New York State Psychiatric Institute
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression; Dysthymia; Depression NOS
Intervention: Escitalopram (Drug); Bupropion (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: New York State Psychiatric Institute Official(s) and/or principal investigator(s):
Jonathan W. Stewart, MD., Principal Investigator, Affiliation: New York State Psychiatric Institute - Columbia University Department of Psychiatry
Summary
Relatively drug naive patients will receive two antidepressant medications as initial
treatment.
Clinical Details
Official title: Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Hamilton Depression Scale (HAM-D)
Secondary outcome: Beck Depression Inventory (BDI)Clinical Global Impression Scale (CGI) Patient Global Impression Scale (PGI) Arizona Sexual Experience Scale (ASEX)
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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)
Locations and Contacts
Depression Evaluation Service - New York State Psychiatric Institute, New York, New York 10032, United States
Additional Information
Depression Evaluation Service - official website New York State Psychiatric Institute - official website
Starting date: February 2005
Last updated: January 14, 2008
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