Dopaminergic Therapy for Anhedonia - 2

Conditions

• Anhedonia
• Depression

Eligibility Criteria

Sex

ALL

Age

25 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Carbidopa Levodopa — DRUG
  Patients will receive between one and three tablets per day of 150 mg L-DOPA (administered with 37.5 mg carbidopa) to achieve doses ranging from 150 to 450 mg/day.
• Placebo — DRUG
  A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive between one and three placebo tablets per day matching the Carbidopa Levodopa tablet.

Study Details

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.

Key Dates

Start date

Nov 21, 2023

Status verified

Jan 2026

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

70 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Carbidopa Levodopa Group
  Patients randomized to the Carbidopa Levodopa Group will receive one tablet per day of L-DOPA (150 mg levodopa administered with 37.5 mg carbidopa) for 4 weeks. Patients that respond after the initial 4 weeks will continue on the same dose for an additional 4 weeks to determine whether clinical response at the 150 mg dose is sustained over time compared to placebo. Patients that do not exhibit a clinical response (50% reduction in HAM-D scores from baseline) after 4-weeks on the 150 mg dose will escalate to 450 mg L-DOPA (three tablets per day of 150 mg levodopa administered with 37.5 mg carbidopa) and studied over an additional 4 weeks (8 weeks total in the study).
• Placebo Comparator: Placebo Group
  Participants will receive placebo tablet. Placebo-treated non-responders at 4 weeks will remain on placebo but with the same instructions to increase daily pill intake.

Primary Outcome Measure

Change in depressive symptom severity measured by Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Baseline, weeks 1-4 post-intervention, weeks 5-8 post-intervention ]

Central Contacts

• Jennifer Felger, PhD
  4047273987
  [email protected]

Locations (1)

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