Leucine in Midlife Depression

Recruiting now · Phase 2

Conditions studied: Major Depression

In brief

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 facts

Study ID

NCT06580145

Run by

Emory University

People needed

75

Starts

2025-02-01

Expected to finish

2029-06-01

Last updated by the study team

2025-04-24

Who can join

Age: 35 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able and willing to provide informed consent
• Diagnosis of major depression per Structured Interview for DSM-V (SCID-V)
• Moderate to severe depression- Inventory of Depressive Symptoms - Self Reported (IDS-SR score >34).
• SHAPS score >30 on the 0-56 scale
• Body mass index (BMI) between 20-35 kg/m2
• Plasma CRP >1 mg/L
• No contraindications to MRI
• Availability of friends or family for transportation after lumbar puncture procedure
• Clinically significant findings on EKG
• Patient Health Questionnaire (PHQ-9) score greater than 10
• Willingness to adopt contraceptive measures. Persons exempt from contraception requirements are:
• Persons assigned male at birth
• Persons assigned female at birth who:
• have undergone a hysterectomy or bilateral oophorectomy; or
• have been naturally postmenopausal for at least 24 consecutive months (i.e., has NOT had menses at any time in the preceding 24 consecutive months)

You may not qualify if…

• 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.
• Current mania/hypomania.
• Substance use disorder in the last 6 months.
• Active suicidal ideation:
• Psychiatric hospitalization in the past year.
• Suicide attempts within the last five years.
• Scores >3 on the Columbia Suicide Severity Rating Scale (C-SSRS)
• Binge eating in the absence of mood symptoms increases.
• Primary diagnosis of severe DSM-V79 anxiety disorders.
• Primary diagnosis of DSM-V PTSD (if severity exceeds major depression).
• Primary diagnosis of DSM-V obsessive-compulsive disorders.
• Significant personality disorders with multiple hospitalizations or suicide attempts.
• Developmental disorders (e.g., ADHD).
• Concomitant medications:
• Immune-active medications (e.g., non-steroidal anti-inflammatory agents).

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.