Are Two Antidepressants a Good Initial Treatment for Depression?
This study has been completed.
Sponsor:
New York State Psychiatric Institute
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00296712
First received: February 24, 2006
Last updated: April 26, 2012
Last verified: April 2012
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Purpose
Relatively drug naive patients will receive two antidepressant medications as initial treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depression Dysthymia Depression NOS |
Drug: escitalopram + bupropion |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication. |
Resource links provided by NLM:
Drug Information available for:
Bupropion hydrochloride
Bupropion
Citalopram hydrobromide
Citalopram
Escitalopram oxalate
U.S. FDA Resources
Further study details as provided by New York State Psychiatric Institute:
Primary Outcome Measures:
- Hamilton Depression Scale (HAM-D) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 55 |
| Study Start Date: | February 2005 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: escitalopram + bupropion
patients begin on escitalopram 10 mg/d, then bupropion 150 mg/d is added and each is alternately increased as tolerated to maximal dose of escitalopram of 40 mg/d and of bupropion of 450 mg/d
|
Drug: escitalopram + bupropion
same dosing as for monotherapy arms
Other Names:
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296712
Locations
| United States, New York | |
| Depression Evaluation Service - New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
| Principal Investigator: | Jonathan W. Stewart, MD. | New York State Psychiatric Institute - Columbia University Department of Psychiatry |
More Information
Additional Information:
No publications provided
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00296712 History of Changes |
| Other Study ID Numbers: | #4653 |
| Study First Received: | February 24, 2006 |
| Last Updated: | April 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York State Psychiatric Institute:
|
Major Depression Dysthymia Depression NOS Escitalopram |
Bupropion Dual Therapy Combination Therapy |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Dysthymic Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Antidepressive Agents Citalopram Bupropion Dexetimide Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |
ClinicalTrials.gov processed this record on June 18, 2013