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RecruitingPhase 4

Dopaminergic Therapy for Anhedonia - 2

Dopaminergic Therapy for Inflammation-Related Anhedonia in Depression - 2

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
25 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks
  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests L-DOPA against a placebo, a pill with no active drug, for 8 weeks. It is for adults ages 25–55 with depression, high inflammation, and anhedonia (trouble feeling pleasure). Study visits include tests and MRI scans, and taking part lasts about 10–12 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Able and willing to give written consent to join.
  • Age 25–55.
  • Have current depression, checked through a mental health interview.
  • Have a depression score above 10 on the PHQ-9 test or at least 18 on the HAM-D test.
  • Have taken no antidepressants or other mental health medicines for at least 4 weeks before the starting visit, or 8 weeks for fluoxetine.
  • Have a CRP blood test result of at least 2 mg/L, showing higher inflammation.
  • Score at least 2 on the PHQ-9 question about trouble feeling pleasure.

Who can't join

  • Have an autoimmune disease (the immune system attacks the body), hepatitis B or C, HIV, or past cancer that needed more than minor surgery.
  • Have an unstable disease affecting the heart, hormones, blood, liver, kidneys, brain, or nerves.
  • Have past or current bipolar disorder or gambling disorder; past psychosis not tied to mood; current psychosis (trouble knowing what is real); alcohol or drug abuse or dependence within 6 months; or a positive urine test for drugs of abuse.
  • Have an active suicide plan or an active eating disorder. Binge eating disorder may be allowed if binges are clearly tied to worsening mood.
  • Have a past disorder affecting memory or thinking, or a head injury that caused loss of consciousness.
  • Are pregnant, breastfeeding, or using gender-affirming hormones.
  • Regularly use NSAIDs (anti-inflammatory pain medicines), steroid medicines called glucocorticoids, or statins (cholesterol medicines). The regular-use rule excepts 81 mg aspirin. Use of NSAIDs, glucocorticoids, or statins during the study is also excluded.
  • Cannot safely have an MRI or take carbidopa-levodopa. This includes drug sensitivity or intolerance, narrow-angle glaucoma (an eye disease), melanoma (a skin cancer), stomach or upper intestine ulcers, bleeding disorders, or frequent migraines.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

GA