Dopaminergic Therapy for Anhedonia - 2
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age25-55
SponsorEmory University
About this trial
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 participants with depression, between 25-55 years of age, with higher levels of inflammation and anhedonia will be randomized to receive L-DOPA or matched placebo over 8 weeks. Participants will complete lab tests, medical and psychiatric assessments, motivation and motor tasks, and MRI scans as part of the study. The total length of participation is approximately 10 to 12 weeks.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Carbidopa Levodopa
- Placebo
Treatment groups
70 Participants
are divided into 2 treatment groupsLocations
1Emory University Hospital30322, AtlantaGeorgia, United States
Sponsors and collaborators
Emory University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov