RecruitingPhase 2NCT06580145

Leucine in Midlife Depression

Leucine as a Probe of Kynurenine-Induced Glutamate and Neural Circuit Dysfunction in Midlife Depression


Sponsor

Emory University

Enrollment

75 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 35 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether leucine — an amino acid found in protein-rich foods — can improve mood and motivation in middle-aged people with moderate to severe depression. Depression in midlife often involves a loss of pleasure and low energy, and leucine may help by supporting brain chemistry related to reward and motivation. **You may be eligible if...** - You have been diagnosed with major depression (confirmed by a structured interview) - Your depression is moderate to severe based on a standard questionnaire - You are a certain age range and BMI (details confirmed at screening) **You may NOT be eligible if...** - You have certain metabolic disorders that affect how your body processes amino acids - You are taking medications that could interact with leucine - You have other major psychiatric conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGL-leucine

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.

DRUGL-lysine

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


Locations(1)

Emory University Hospital

Atlanta, Georgia, United States

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NCT06580145


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