Status:
COMPLETED
DTA (Dopaminergic Therapy for Anhedonia) Study
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Anhedonia
Eligibility:
All Genders
25-55 years
Phase:
PHASE4
Brief Summary
The purpose of this 6-week, double-blind, placebo-controlled, crossover study is to explore new treatment options for people with depression who have high inflammation and anhedonia. Thirty-five male ...
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
- willing and able to give written informed consent;
- men or women, 25-55 years of age
- a primary diagnosis of DSM-V MD, current, as diagnosed by the SCID-I;
- score \>10 on the Patient Health Questionnaire \[PHQ\]-9
- 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)
- CRP ≥2 mg/L
- Score \>/=2 on the anhedonia question of Patient Health Questionnaire \[PHQ\]-9
Exclusion
- history or evidence (clinical or laboratory) of an autoimmune disorder ;
- history or evidence (clinical or laboratory) 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, EKG and laboratory testing);
- 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 SCID);
- 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) ;
- a history of a cognitive disorder
- pregnancy or lactation;
- chronic use of non-steroidal anti-inflammatory agents (NSAIDS) (excluding 81mg of aspirin), glucocorticoid containing medications or statins;
- use of NSAIDS, glucocorticoids, or statins at any time during the study;
- urine toxicology screen is positive for drugs of abuse,
- any contraindication for MRI scanning; n. 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 :
January 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04723147
Start Date
January 29 2021
End Date
October 11 2023
Last Update
December 16 2024
Active Locations (1)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322