| February 24, 2006 |
| January 14, 2008 |
| February 2005 |
| July 2006 (final data collection date for primary outcome measure) |
| Hamilton Depression Scale (HAM-D) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ] |
| Hamilton Depression Scale (HAM-D) |
| Complete list of historical versions of study NCT00296712 on ClinicalTrials.gov Archive Site |
- Beck Depression Inventory (BDI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impression Scale (CGI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- Patient Global Impression Scale (PGI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
- Arizona Sexual Experience Scale (ASEX) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
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- Beck Depression Inventory (BDI)
- Clinical Global Impression Scale (CGI)
- Patient Global Impression Scale (PGI)
- Arizona Sexual Experience Scale (ASEX)
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| |
| Are Two Antidepressants a Good Initial Treatment for Depression? |
| Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication. |
Relatively drug naive patients will receive two antidepressant medications as initial treatment. |
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. |
| Phase IV |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
- Major Depression
- Dysthymia
- Depression NOS
|
- Drug: Escitalopram
- Drug: Bupropion
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| |
| |
| |
| Completed |
| 55 |
|
| July 2006 (final data collection date for primary outcome measure) |
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)
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| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00296712 |
| Jonathon W. Stewart, M.D., New York State Psychiatric Institute |
| IRB4653 |
| New York State Psychiatric Institute |
|
| Principal Investigator: |
Jonathan W. Stewart, MD. |
New York State Psychiatric Institute - Columbia University Department of Psychiatry |
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| New York State Psychiatric Institute |
| January 2008 |