Bupropion Versus Escitalopram on Reward Circuitry and Motivational Deficits

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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 patients with increased inflammation and anhedonia. Participants will be randomized to take bupropion extended release (XL) or escitalopram for 8 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Bupropion; Citalopram

Criteria

Inclusion Criteria:

• 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 (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

• IDS-SR anhedonia subscale score ≥5

Exclusion Criteria:

• 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