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New treatment option for Anhedonia
Official title Dopaminergic Therapy for Anhedonia - 2
ClinicalTrials.gov ID: NCT06075771
What this study is testing
What is Carbidopa Levodopa?
Carbidopa Levodopa is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for anhedonia.
Also referred to as Sinemet, L-DOPA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 8 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 55
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- e. history of any (non-mood-related) psychotic disorder; active psychotic symptoms of any type; history or current bipolar disorder; history or...
- f. active suicidal plan as determined by a score \>3 on item #3 on the HAM-D
See the full eligibility 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
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.