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Sleep/Wake Cycle and Depression: An Imaging and Treatment Study

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Conditions

Depression; Major Depressive Disorder

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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

16.2 million American adults are affected by depression each year. The investigators are studying the relationship between sleep/wake cycle and depression. Mounting evidence suggests that abnormalities in circadian rhythms (biological changes that happen over the course of the day or night) are related to mood disorders. This may explain why people with depression frequently suffer with sleeping problems. The purpose of this study is to understand how circadian (sleep/wake) rhythms may be affected in depression and the best way to improve depression caused in this way. This will be performed by comparing circadian (sleep/wake) rhythms in people with and without depression. The study involves being kept awake for one night. For depressed individuals, this technique will likely result in a brief (\<1 day) improvement in depression. Following this study, participants with depression will be offered antidepressant medication at no cost. During the study, the investigators use brain scans to learn more about brain chemistry in health and depression.

Official Title

Role of the Metabotropic Glutamate Receptor Subtype 5 in Circadian Rhythm Misalignment and Depression: Implications for Treatment

Quick Facts

Study Start:2020-09-01
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04350567

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 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Participant considered at significant risk for suicide
  2. * Unlikely to tolerate medication washout or the drug free period following washout (depressed participants only)
  3. * Current psychosis
  4. * ECT within 4 weeks of the first overnight visit
  5. * Significant active physical illness or neurological deficit that may affect brain function or imaging
  6. * A disease, job or life circumstance that creates an irregular circadian rhythm anticipated during the study
  7. * Inability to maintain in bed and out of bed (regardless of sleep time, for depressed individuals) or sleep and wake times (for non-depressed individuals) to within \~30 min for a week before each overnight visit (will be measured by actigraphy and/or other measurements)
  8. * Inability to abstain from medications that will affect glutamate levels or circadian rhythms, including stimulants, anti-epileptics, antidepressants, beta-blockers, hypnotics (including benzodiazepines), melatonin, or medications with glutamateric or GABAergic modes of action within 4 weeks before the first overnight visit as well as throughout the study
  9. * Inability to reduce caffeine intake to \<= \~300 mg of caffeine (\~2.5 cups of coffee or equivalents) daily within 4 weeks of the first overnight visit as well as throughout the study
  10. * Inability to abstain from nicotine within 4 weeks before the first overnight visit as well as throughout the study
  11. * Inability to reduce use of alcohol to \<= \~5 drinks per week from 4 weeks before the first overnight visit and throughout the study and to completely abstain from alcohol within 24 hours of any overnight visit
  12. * Inability to abstain from significant substance use (including cannabis) within 4 weeks before the first overnight visit as well as throughout the study
  13. * Planned intermittent fasting or calorie restricted diet within 4 weeks before the first overnight visit as well as throughout the study
  14. * For females: Pregnancy within the past year, currently lactating; planning to conceive during the course of study participation, or abortion in the past two months
  15. * Any MRI contraindications, including metal implants, pacemaker, metal prostheses, orthodontic appliances, or presence of shrapnel that are contraindicated for MRI
  16. * Any PET contraindications, including if study imaging will result in the participant receiving greater exposure than the research limit, or if participant is currently breastfeeding

Contacts and Locations

Study Locations (Sites)

Stony Brook University Hospital
Stony Brook, New York, 11794
United States

Collaborators and Investigators

Sponsor: 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 Date2020-09-01
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2020-09-01
Study Completion Date2025-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Depression; Major Depressive Disorder