NCT06580145 · Emory University
Leucine in Midlife Depression
What this study 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 treatment group$1 (lysine) for 6 weeks.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 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.
- 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: \-- Location and quantity of metallic objects safe to MR
- Concomitant Treatment for Depression: \-- Treatments with antidepressant medications or those with antidepressant effects (dopamine supplements).
- 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
- Pregnant women.
- Individuals unable to consent
Where
- Atlanta, Georgia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 24, 2025 · Source of record for eligibility and locations