Leucine in Midlife Depression

Launched by EMORY UNIVERSITY · Aug 29, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Leucine in Midlife Depression," is looking at how a substance called leucine might affect brain function and behavior in people who are experiencing major depression during midlife. The study will last for 6 weeks and will compare the effects of leucine to another substance called lysine to see which one has a better impact on mood and brain chemistry. Researchers are currently recruiting participants between the ages of 18 and 65 who have been diagnosed with moderate to severe depression and meet certain health criteria.

To be eligible for this trial, participants must be able to give their consent and have a confirmed diagnosis of major depression. They should have a specific score on a depression scale and meet health requirements like having a body mass index (BMI) within a certain range. Participants can expect to come in for assessments, including an MRI scan, and will receive either leucine or lysine during the trial. It's important to know that individuals with certain medical conditions, those taking specific medications, or those with a history of severe psychiatric disorders may not be eligible to participate. This trial aims to provide insights that could help improve treatment options for those struggling with depression.

Gender

ALL

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