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Dopaminergic Therapy for Anhedonia - 2

Study acronym: DTA-2
StatusRecruiting
PhasePhase 4
Started2023-11-21
View on ClinicalTrials.gov ↗

Amendment history

2026-01-26
Study Status v3
Re-verified, no change to tracked fields
2025-01-16
Study Status, Contacts/Locations v2
Study sitescontacts updated at 1 of 1 site
2024-01-08
Not Yet Recruiting→Recruiting Study Identification, Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-11→confirmed 2023-11-21
Eligibility criteria+134 characters
Inclusion Criteria: 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-V MD5), current, as diagnosed by the SCIDStructured Clinical Interview for DSM-V;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. [...] 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 Criteria: a. history or evidence [...] [...]
Study sitesdetails revised at 1 of 1 site
Study title-7 characters
DTA-2: Dopaminergic Therapy for Anhedonia - 2
2023-10-04
Original filing
Emory University
371 trials monitored
See 23 trials at risk
Depression
2,976 trials monitored
See 162 trials at risk
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.
Trial Details
NCT Number NCT06075771
Lead Sponsor Emory University
Collaborators: National Institute of Mental Health (NIMH)
Conditions Anhedonia, Depression
Enrollment 70 participants
Start Date 2023-11-21
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-28