Dopaminergic Therapy for Anhedonia - 2

Launched by EMORY UNIVERSITY · Oct 4, 2023

Keywords

ClinConnect Summary

This clinical trial, called "Dopaminergic Therapy for Anhedonia - 2," is looking at a potential new treatment for people aged 25 to 55 who are experiencing depression and a specific symptom called anhedonia, which is the inability to feel pleasure. The study will last for about 10 to 12 weeks and involves 70 participants who will receive either a medication called L-DOPA or a placebo (a pill that looks the same but contains no active medication). The goal is to see if L-DOPA can help improve mood and reduce inflammation, which is linked to depression.

To join the study, participants need to meet certain criteria, such as being diagnosed with depression and having elevated levels of inflammation. They should also be off any antidepressants or other psychiatric medications for at least four weeks prior to starting the trial. Throughout the study, participants will undergo various evaluations, including lab tests and brain scans, to monitor their health and response to the treatment. This research could provide new insights into treating depression, especially for those struggling with high inflammation and anhedonia.

Gender

ALL

Eligibility criteria

• 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 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)