Does Dual Therapy Hasten Antidepressant Response?
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Purpose
This study will utilize a randomized double-blind design to evaluate whether initial treatment with two anti-depressant medications (escitalopram and bupropion) results in more rapid remission and greater over-all remission rates than either monotherapy in 240 depressed subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: escitalopram Drug: bupropion XL Drug: escitalopram + bupropion |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Combining Antidepressants to Hasten Remission From Depression |
- Time to remission, defined by the week of onset of persistent HAM-D 17 <= 7, with no subsequent HAM-D 17 > 7 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Remission: persistent HAM-D 17 <= 7, with no HAM-D 17 >7 through week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Severity of depressive symptoms, measured by HAM-D 17, CGI, QIDS-SR 16 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Functioning, as measured by the SAS functioning summary score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Quality of Life, as measured by the Q-LES-Q short form [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 245 |
| Study Start Date: | August 2007 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: escitalopram + bupropion
escitalopram plus bupropion XL
|
Drug: escitalopram + bupropion
same dosing schedule as for monotherapy
Other Names:
|
|
Active Comparator: escitalopram
escitalopram monotherapy
|
Drug: escitalopram
10mg/d increasing by 10 mg/week to a maximum of 40 mg/d if tolerated and not remitted
Other Name: Lexapro
|
|
Active Comparator: bupropion
bupropion XL monotherapy
|
Drug: bupropion XL
150mg/d increasing to 300 mg/d after 1 week and 450 mg/d after 3 weeks, all increases if tolerated and not remitted
Other Name: Welbutrin XL
|
Detailed Description:
Depression is a major public health problem due to its prevalence and accompanying dysfunction and costs. Depression is undertreated, but even when treatment is adequate and effective, sources of delay in current pharmacologic strategies include: mechanistic delays, those related to the physiologic and behavioral effects of antidepressants; dosing delays in identifying the effective dose; and programmatic delays in identifying an effective agent using sequential monotherapy. This study will randomize 240 patients with DSM-IV Major Depressive Disorder to 12 week double blind treatment with combined escitalopram and bupropion or each antidepressant administered alone to evaluate whether combined escitalopram and bupropion result in more rapid remission and greater over-all remission than monotherapy. Preclinical and clinical studies suggest that bupropion might prevent one mechanistic delay inherent in escitalopram monotherapy. Rapid dose escalation may counter dosing delays. The simultaneous use of two known antidepressant medications may alleviate programmatic delays inherent in usual sequential monotherapy. Six months follow up and careful assessment of adverse events will address tolerability, acceptability, sustainability, and pharmacoeconomic concerns. If successful, this study might have a significant impact on clinical practice, public health, and depression's cost consequences.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women ages 18-65
- Major Depressive Disorder as primary diagnosis
- Physically healthy
- Signs informed consent
- Montgomery Asberg Depression Rating Scale (MADRS) >= 22
Exclusion Criteria:
- Bipolar Disorder (ie, Bipolar I, Bipolar II, Bipolar NOS)
- Life-time history of psychosis
- Current (ie, last 6 months) drug or alcohol abuse or dependence (except nicotine)
- Currently taking effective antidepressant medication
- Prior adequate treatment in current depressive episode with a SSRI, BUP or BUP + SSRI ("adequate" is defined as >= 4 weeks taking >= 2/3 PDR maximal dose)
- Most recent antidepressant was within 5 weeks for fluoxetine and 1 week for all others
- Currently taking a medication contraindicated with either study medication
- Life time history of anorexia or bulimia
- Life time history of seizure or known increased seizure risk (e.g., history of significant brain trauma, taking pro-convulsant medication, known anatomical brain lesion)
- Currently taking psychoactive medication deemed to be necessary (including but not limited anticonvulsants, antidepressants, antipsychotics, steroids, and B-blockers); occasional use of hypnotics (ie, less than three times per week) will be allowed
- Unstable medical condition (ie, condition not adequately stabilized for >= 3 months)
- Prior intolerance to ESC or BUP
- Inadequate understanding of English (for US site; Canadian site permits French fluency)
- Currently pregnant or breast-feeding; fecund women not using adequate contraceptive methods
Contacts and Locations| United States, New York | |
| New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
| Canada, Ontario | |
| University of Ottawa, Institute of Mental Health Research | |
| Ottawa, Ontario, Canada, K1Z7K4 | |
| Principal Investigator: | Jonathan W. Stewart, M.D. | New York State Psychiatric Institute |
| Principal Investigator: | Pierre Blier, M.D. | University of Ottawa, Institute of Mental Health Research |
More Information
Additional Information:
No publications provided
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00519428 History of Changes |
| Other Study ID Numbers: | 5476, 5R01MH076961-04 |
| Study First Received: | August 20, 2007 |
| Last Updated: | June 26, 2012 |
| Health Authority: | United States: Institutional Review Board Canada: Canadian Institutes of Health Research Canada: Ethics Review Committee Canada: Health Canada |
Keywords provided by New York State Psychiatric Institute:
|
depression MDD Major Depressive Disorder |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms 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 Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013