Status:
RECRUITING
Leucine in Midlife Depression
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depression
Eligibility:
All Genders
35-65 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Major depression is a common and serious mental health condition that can severely impact a person's quality of life. Some symptoms, like loss of pleasure in activities and slowed movements, may be si...
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:
- \-- 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
- Population
- Pregnant women.
- Children.
- Prisoners.
- Individuals unable to consent
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06580145
Start Date
February 1 2025
End Date
June 1 2029
Last Update
April 24 2025
Active Locations (1)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322