Dopaminergic Therapy for Anhedonia - 2
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 randomiz
| Condition(s) | Anhedonia, Depression |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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 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. |
| Who can participate | 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-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 Criteria: * a. history or evidence (clinical or laboratory) of an autoimmune disorder * b. history or evidence (clinical or laboratory) of hepati |
| Ages | 25 Years to 55 Years |
| Sex | All |
| Lead sponsor | Emory University |
| Locations | Atlanta, Georgia, United States |
| Start date | 2023-11-21 |
| NCT ID | NCT06075771 |
| Official listing | https://clinicaltrials.gov/study/NCT06075771 |