RECRUITING

Leucine in Midlife Depression

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Conditions

Major DepressionKynurenine (KYN) pathwayLeucine in Midlife Depression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02
Study Completion:2029-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06580145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able and willing to provide informed consent
  2. * Diagnosis of major depression per Structured Interview for DSM-V (SCID-V)
  3. * Moderate to severe depression- Inventory of Depressive Symptoms - Self Reported (IDS-SR score \>34).
  4. * SHAPS score \>30 on the 0-56 scale
  5. * Body mass index (BMI) between 20-35 kg/m2
  6. * Plasma CRP \>1 mg/L
  7. * No contraindications to MRI
  8. * Availability of friends or family for transportation after lumbar puncture procedure
  9. * Clinically significant findings on EKG
  10. * Patient Health Questionnaire (PHQ-9) score greater than 10
  11. * Willingness to adopt contraceptive measures. Persons exempt from contraception requirements are:
  12. * Persons assigned male at birth
  13. * Persons assigned female at birth who:
  14. * have undergone a hysterectomy or bilateral oophorectomy; or
  15. * 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)
  1. * Leucine-Specific:
  2. * History of maple syrup urine disease
  3. * Risk of hypoglycemia (unstable diabetes)
  4. * History of vitamin B6 deficiency, relative
  5. * Lysine-Specific:
  6. * On calcium supplements, relative
  7. * History of renal/gall stones (could cleared by a primary care provider)
  8. * Cognitive:
  9. * Psychiatric Disorders:
  10. * Lifetime diagnosis of psychotic disorders.
  11. * Current mania/hypomania.
  12. * Substance use disorder in the last 6 months.
  13. * Active suicidal ideation:
  14. * Psychiatric hospitalization in the past year.
  15. * Suicide attempts within the last five years.
  16. * Scores \>3 on the Columbia Suicide Severity Rating Scale (C-SSRS)
  17. * Binge eating in the absence of mood symptoms increases.
  18. * Primary diagnosis of severe DSM-V79 anxiety disorders.
  19. * Primary diagnosis of DSM-V PTSD (if severity exceeds major depression).
  20. * Primary diagnosis of DSM-V obsessive-compulsive disorders.
  21. * Significant personality disorders with multiple hospitalizations or suicide attempts.
  22. * Developmental disorders (e.g., ADHD).
  23. * Concomitant medications:
  24. * Immune-active medications (e.g., non-steroidal anti-inflammatory agents).
  25. * Antibiotics and immunizations in the past 2 weeks.
  26. * Topical or inhaled steroids within the past week.
  27. * Oral/parenteral steroids in the last 6 months.
  28. * Supplements that impact the immune system (e.g., omega-3, probiotics) within the past 2 weeks.
  29. * Psychotropic medications within the last 4 weeks (8 weeks for fluoxetine).
  30. * Daily use of sedative-hypnotics, benzodiazepines, and opiates.
  31. * Medical Disorders:
  32. * Unstable medical disorders (frequent provider or medication changes).
  33. * Lifetime diagnosis/treatment of cancers (excluding basal cell carcinoma).
  34. * Lifetime diagnosis/treatment of autoimmune disorders.
  35. * Lifetime exposure to chemotherapeutic agents.
  36. * MRI Considerations:
  37. * Concomitant Treatment for Depression:
  38. * Treatment for General Medical Conditions (GMCs):
  39. * Stabilized medications are allowed if maintained at the same dose during the trial.
  40. * Multiple recent changes in concomitant medications reviewed by the study PI
  41. * Population
  42. * Pregnant women.
  43. * Children.
  44. * Prisoners.
  45. * Individuals unable to consent

Contacts and Locations

Study Contact

Ebrahim Haroon, MD
CONTACT
(404) 727-8229
eharoon@emory.edu
Diana Beltran, BS
CONTACT
404-712-7686
djbeltr@emory.edu

Principal Investigator

Ebrahim Haroon, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory University Hospital
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Ebrahim Haroon, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02
Study Completion Date2029-07

Study Record Updates

Study Start Date2025-02
Study Completion Date2029-07

Terms related to this study

Keywords Provided by Researchers

  • Major Depression
  • Kynurenine (KYN) pathway
  • Leucine in Midlife Depression

Additional Relevant MeSH Terms

  • Major Depression