RightFit
RecruitingPhase 2

Leucine in Midlife Depression

Leucine as a Probe of Kynurenine-Induced Glutamate and Neural Circuit Dysfunction in Midlife Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
35 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The researchers will compare the leucine and an active comparator arm (lysine) for 6 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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 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

Study sites (1)

GA