Leucine in Midlife Depression

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06580145
Phase
PHASE2
Status
Recruiting
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Conditions

  • Major Depression

Eligibility Criteria

Sex
ALL
Age
35 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • L-leucine — DRUG
    L-leucine is an essential amino acid used to competitively inhibit kynurenine uptake into the brain via the large neutral amino acid transporter (LAT1). The proposed dose for L-leucine is 4.31 g/day, administered orally.
  • L-lysine — DRUG
    L-lysine monohydrochloride is also an essential amino acid. It serves as an active comparator to control for general effects on brain protein synthesis and enters the brain through separate cationic amino acid transporters. The proposed dose for L-lysine is 6 g/day, administered orally

Study Details

The study aims to investigate the effects of a 6-week leucine challenge on brain chemistry, connectivity, and behavior in people with midlife depression. The researchers will compare the leucine and an active comparator arm (lysine) for 6 weeks.

Key Dates

Start date
Feb 1, 2025
Status verified
Apr 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: L-leucine
  • Active Comparator: L-lysine

Primary Outcome Measure

Change in Glutamate [ Time Frame: Baseline, Week 1, Week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322
Ebrahim Haroon, MD
[email protected]
404-712-2890

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By research site
Emory University Hospital· Atlanta, GA

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