No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
35 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
75 (estimated)
Sponsor
Emory University · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
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 inde…
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
* Population
* Pregnant women.
* Children.
* Prisoners.
* Individuals unable to consent
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