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Leucine for Midlife Depression

This study is looking into how L-leucine, an essential amino acid, might help people aged 35 to 65 with moderate to severe major depression. Researchers believe that L-leucine could block harmful substances from entering the brain, which are thought to contribute to depression, especially when there's inflammation. You might be eligible if you have a diagnosis of major depression, a high score on a depression symptom scale (IDS-SR >34), and a certain level of inflammation (Plasma CRP >1 mg/L). The main goal is to see how L-leucine affects brain chemistry, specifically changes in Glutamate, over 6 weeks. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 75 participants. Participants will receive either L-leucine or L-lysine for 6 weeks.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Changes in Glutamate will be measured at Baseline, Week 1, and Week 6.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06580145

Leucine in Midlife Depression

Recruiting
PHASE2Ages 35–65InterventionalTreatment
Emory University
~75 participants
Updated 2025-04-24 on ClinicalTrials.gov
What's tested:L-leucineL-lysine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Glutamate
Measured over Baseline, Week 1, Week 6

Conditions

Major Depression

Explore related trials

Unipolar DepressionCRP Gene

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Ebrahim Haroon, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Ebrahim Haroon, MD
[email protected]
(404) 727-8229
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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).
Antibiotics and immunizations in the past 2 weeks.
Topical or inhaled steroids within the past week.
Oral/parenteral steroids in the last 6 months.
Supplements that impact the immune system (e.g., omega-3, probiotics) within the past 2 weeks.
Psychotropic medications within the last 4 weeks (8 weeks for fluoxetine).
Daily use of sedative-hypnotics, benzodiazepines, and opiates.
Medical Disorders:
Unstable medical disorders (frequent provider or medication changes).
Lifetime diagnosis/treatment of cancers (excluding basal cell carcinoma).
Lifetime diagnosis/treatment of autoimmune disorders.
Lifetime exposure to chemotherapeutic agents.
MRI Considerations:
Concomitant Treatment for Depression:
Treatment for General Medical Conditions (GMCs):
Stabilized medications are allowed if maintained at the same dose during the trial.
Multiple recent changes in concomitant medications reviewed by the study PI
Population
Pregnant women.
Children.
Prisoners.
Individuals unable to consent

What this trial measures

  • Change in GlutamateBaseline, Week 1, Week 6

    Change in glutamate measured by magnetic resonance spectroscopy (MRS) in the basal ganglia in the leucine challenged group compared with the lysine-challenged group.