Status:
COMPLETED
Bupropion Versus Escitalopram on Reward Circuitry and Motivational Deficits
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depression
Eligibility:
All Genders
25-55 years
Phase:
PHASE4
Brief Summary
This study is designed to determine whether bupropion (vs escitalopram) increases functional connectivity (FC) within reward-related neurocircuits and decreases motivational deficits in depressed pati...
Detailed Description
The goal of the proposed research is to determine the mechanism of action of an antidepressant of known efficacy (bupropion) and to tie this mechanism of action to a biomarker of inflammation in suppo...
Eligibility Criteria
Inclusion
- willing and able to give written informed consent
- a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM-V) MD, current as diagnosed by the Structured Clinical Interview for DSM-V Axis I Disorders (SCID-V)
- score of ≥16 on the 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR)
- off all antidepressant or other psychotropic therapy (e.g. mood stabilizers, antipsychotics, and sedative hypnotics) for at least 4 weeks prior to baseline visit (8 weeks for fluoxetine); concomitant administration of up to 2 mg of clonazepam or its equivalent per day will be allowed, but not within 12 hours of study assessments
- CRP\>2mg/L
- Inventory of Depressive Symptomatology (IDS-SR) anhedonia subscale score ≥5
Exclusion
- history of any autoimmune disorder
- history of hepatitis B or C infection or human immunodeficiency virus infection
- history of any type of cancer requiring treatment with more than minor surgery
- unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination and laboratory testing)
- history of any (non-mood-related) psychotic disorder; active psychotic symptoms of any type; substance abuse/dependence within 6 months of study entry (as determined by SCID)
- an active eating disorder or antisocial personality disorder
- a history of a cognitive disorder or ≤28 on the Mini-Mental State Exam unless otherwise approved by the PI
- pregnancy or lactation
- chronic use of non-steroidal anti-inflammatory agents (NSAIDS) (excluding 81mg of aspirin), glucocorticoid containing medications
- use of NSAIDS or oral glucocorticoids at any time during the study
- any contraindication for MRI scanning
- failure of more than 2 antidepressant trials in the current episode
- Intolerance of bupropion or escitalopram
- BMI \>40 (to exclude severe obesity)
- due to the high co-morbidity between anxiety disorders and depression, the study team plans to include patients with anxiety-related disorders excluding obsessive-compulsive disorder (OCD) if depression is the primary diagnosis. Patients with stable medical conditions and on medications for those conditions will not be excluded. Concomitant administration of up to 2 mg of clonazepam or its equivalent per day will be allowed, but not within 12 hours of study assessments.
- sexually active participants are required to use medically approved birth control methods as defined in the Birth Control Method Form for the duration of the study
Key Trial Info
Start Date :
September 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04352101
Start Date
September 23 2020
End Date
July 25 2022
Last Update
December 29 2023
Active Locations (1)
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1
Emory Clinic
Atlanta, Georgia, United States, 30322