Depression NOS, Dysthymia, Major Depression
Conditions
Keywords
Major Depression, Dysthymia, Depression NOS, Escitalopram, Bupropion, Dual Therapy, Combination Therapy
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.
Interventions
same dosing as for monotherapy arms
Sponsors
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale (HAM-D) | 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Beck Depression Inventory (BDI) | 10 weeks |
| Clinical Global Impression Scale (CGI) | 10 weeks |
| Patient Global Impression Scale (PGI) | 10 weeks |
| Arizona Sexual Experience Scale (ASEX) | 10 weeks |
Countries
United States
Outcome results
None listed