Actively Recruiting
Leucine in Midlife Depression
Led by Emory University · Updated on 2025-04-24
75
Participants Needed
1
Research Sites
225 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Leucine in Midlife Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide informed consent
- Diagnosis of major depression per Structured Interview for DSM-V (SCID-V)
- Moderate to severe depression with Inventory of Depressive Symptoms - Self Reported (IDS-SR) score greater than 34
- SHAPS score greater than 30 on the 0-56 scale
- Body mass index (BMI) between 20-35 kg/m2
- Plasma C-reactive protein (CRP) greater than 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 unless exempt due to male sex, hysterectomy, bilateral oophorectomy, or natural postmenopause for at least 24 months
You will not qualify if you...
- History of maple syrup urine disease
- Risk of hypoglycemia (unstable diabetes)
- History of vitamin B6 deficiency
- Current use of calcium supplements
- History of renal or gall stones unless cleared by a primary care provider
- Cognitive impairment with MMSE score less than 28
- Lifetime diagnosis of psychotic disorders
- Current mania or hypomania
- Substance use disorder in the last 6 months
- Active suicidal ideation or psychiatric hospitalization in the past year
- Suicide attempts within the last five years
- Scores greater than 3 on the Columbia Suicide Severity Rating Scale (C-SSRS)
- Binge eating without mood symptoms increasing
- Primary diagnosis of severe anxiety, PTSD exceeding depression severity, obsessive-compulsive disorder
- Significant personality disorders with multiple hospitalizations or suicide attempts
- Developmental disorders such as ADHD
- Use of immune-active medications, antibiotics, immunizations, or steroids within specified recent time frames
- Use of psychotropic medications within the last 4 weeks (8 weeks for fluoxetine)
- Daily use of sedative-hypnotics, benzodiazepines, or opiates
- Unstable medical disorders with frequent provider or medication changes
- Lifetime diagnosis or treatment of cancers (excluding basal cell carcinoma) or autoimmune disorders
- Lifetime exposure to chemotherapeutic agents
- Unsafe metallic objects for MRI
- Use of antidepressant medications or treatments with antidepressant effects
- Pregnant women, children, prisoners, or individuals unable to consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
E
Ebrahim Haroon, MD
CONTACT
D
Diana Beltran, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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