🏛️ Verified NIH Record • Updated 2025-04-20

Leucine in Midlife Depression (NCT06580145)

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Emory University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (15 items) and avoid the listed exclusions (47 items).

Location: Emory University Hospital — Atlanta, Georgia

Age range: 35 Years to 65 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Leucine-Specific:
  • History of maple syrup urine disease
  • Risk of hypoglycemia (unstable diabetes)
  • History of vitamin B6 deficiency, relative
  • Lysine-Specific:
  • On calcium supplements, relative
  • History of renal/gall stones (could cleared by a primary care provider)
  • Cognitive:
  • Cognitive impairment (MMSE score \<28)
  • Psychiatric Disorders:
  • Lifetime diagnosis of psychotic disorders.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Emory University Hospital — Atlanta, Georgia

📞 Contact the Study Coordinator

Phone: (404) 727-8229

Email: eharoon@emory.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Major Depression clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗