RECRUITING

PET Imaging Using the Tracer [18F]VAT to Assess the Antidepressant Effect of Nicotine.

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Conditions

Major Depressive Disorder (MDD)

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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

In the brain, certain nerve cells communicate using a chemical called acetylcholine. Acetylcholine is thought to be important for several functions including mood, memory and wakefulness. The purpose of this study is to explore the role of these nerve cells in depression. Also, we would like to understand how nicotine, the study drug, works in depression and how it affects these nerve cells. To do this, brain imaging will be used before and after this treatment.

Official Title

Central Cholinergic Dysfunction in Depression: PET Imaging of a Novel Treatment Target With [18F]VAT to Assess the Antidepressant Effect of Nicotine

Quick Facts

Study Start:2024-10-03
Study Completion:2029-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07095205

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:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age range 18 to 65 years old.
  2. * Capacity to consent (able to read, understand, and sign informed consent).
  3. * Age range 18 to 65 years old.
  4. * Capacity to consent (able to read, understand, and sign informed consent).
  5. * Major Depressive Disorder (MDD) as primary diagnosis and currently in a major depressive episode
  6. * Score of at least 29 on the Montgomery-Asberg Depression Rating Scale (MADRS).
  1. * Nicotine use, including tobacco, e-cigarettes, nicotine patch, nicotine gum, within the past year \[except for occasional users, who cannot use nicotine products in the week before the scan\].
  2. * Need for use of medication during the study that will affect cholinergic levels.
  3. * Problematic drug/alcohol use that is judged sufficient to interfere with study procedures during the treatment period or impact participant safety.
  4. * Significant active physical illness or neurological deficit that may affect brain function or imaging.
  5. * Significant eye conditions such as keratoconus and/or need for rigid contact lenses.
  6. * Current or lifetime history of a major psychiatric diagnosis.
  7. * Any MRI contraindications, including recent tattoos, metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI.
  8. * Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is pregnant, currently breastfeeding, or planning to conceive during the course of study participation.
  9. * Blood donation within 8 weeks of the \[18F\]VAT scan.
  10. * Nicotine use, including tobacco, e-cigarettes, nicotine patch, nicotine gum, within the past year \[except for occasional users, who cannot use nicotine products in the week before the scan\].
  11. * Currently on effective antidepressant medications or need for use of medications that target the cholinergic system.
  12. * Problematic drug/alcohol use that is judged sufficient to interfere with study procedures during the treatment period or impact participant safety.
  13. * Significant active physical illness or neurological deficit that may affect the brain function or imaging.
  14. * Significant eye conditions such as keratoconus and/or need for rigid contact lenses.
  15. * Current or lifetime major psychiatric diagnosis other than MDD.
  16. * Life-time history of psychosis or current psychosis.
  17. * Significant risk for suicide.
  18. * Any MRI contraindications, including recent tattoos, metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI.
  19. * Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is pregnant, currently breastfeeding, or planning to conceive during the course of study participation.
  20. * Blood donation within 8 weeks of the \[18F\]VAT scan.

Contacts and Locations

Study Contact

Julianna Lizzul
CONTACT
631-638-0291
julianna.lizzul@stonybrookmedicine.edu

Principal Investigator

Ramin Parsey, MD, PhD
PRINCIPAL_INVESTIGATOR
Stony Brook University

Study Locations (Sites)

Stony Brook University: Dept of Psychiatry
Stony Brook, New York, 11794
United States

Collaborators and Investigators

Sponsor: Stony Brook University

  • Ramin Parsey, MD, PhD, PRINCIPAL_INVESTIGATOR, Stony Brook 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 Date2024-10-03
Study Completion Date2029-09-30

Study Record Updates

Study Start Date2024-10-03
Study Completion Date2029-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Major Depressive Disorder (MDD)