Status:
RECRUITING
Dopaminergic Therapy for Anhedonia - 2
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Anhedonia
Depression
Eligibility:
All Genders
25-55 years
Phase:
PHASE4
Brief Summary
The purpose of this 8-week, double-blind, placebo-controlled, study is to explore new treatment options for people with depression who have high inflammation and anhedonia. Seventy male and female par...
Detailed Description
Depression is a widespread disorder (lifetime prevalence \>20%). Current antidepressant medications are effective for many patients; however, more than 30% fail to respond. Of the patients that do res...
Eligibility Criteria
Inclusion
- a. willing and able to give written informed consent
- b. men or women, 25-55 years of age
- c. a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), current, as diagnosed by the Structured Clinical Interview for DSM-5
- d. score of \>10 on the Patient Health Questionnaire-9 (PHQ-9) or HAM-D score ≥18
- e. off all antidepressant or other psychotropic therapy (e.g. mood stabilizers, antipsychotics, anxiolytics, and sedative hypnotics) for at least 4 weeks prior to baseline visit (8 weeks for fluoxetine)
- f. c-reactive protein (CRP) ≥2 mg/L
- g. PHQ-9 anhedonia score ≥2
Exclusion
- a. history or evidence (clinical or laboratory) of an autoimmune disorder
- b. history or evidence (clinical or laboratory) of hepatitis B or C infection or human immunodeficiency virus infection
- c. history of any type of cancer requiring treatment with more than minor surgery
- d. unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination, EKG and laboratory testing)
- e. history of any (non-mood-related) psychotic disorder; active psychotic symptoms of any type; history or current bipolar disorder; history or current gambling disorder; substance abuse/dependence within 6 months of study entry (as determined by standardized clinician interview)
- f. active suicidal plan as determined by a score \>3 on item #3 on the HAM-D
- g. an active eating disorder (except for patients with binge eating disorder in whom binging is clearly associated with worsening of mood symptoms)
- h. a history of a cognitive disorder or traumatic head injury involving loss of consciousness
- i. pregnancy or lactation
- j. use of gender affirming hormone therapy
- k. chronic use of non-steroidal anti-inflammatory agents (NSAIDS) (excluding 81mg of aspirin), glucocorticoid containing medications or statins
- l. use of NSAIDS, glucocorticoids, or statins at any time during the study
- m. urine toxicology screen is positive for drugs of abuse, n. any contraindication for MRI scanning
- o. intolerance, sensitivity or contraindication to carbidopa-levodopa (including history of narrow-angle glaucoma, melanoma, gastric and/or duodenal ulcers, bleeding disorders, or frequent migraines)
Key Trial Info
Start Date :
November 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06075771
Start Date
November 21 2023
End Date
January 1 2027
Last Update
January 17 2025
Active Locations (1)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322