RECRUITING

The Role of mGluR5 in CBT-I

Talk to us

Conditions

Major Depressive Disorder (MDD)Cognitive Behavioral TherapyCBT-ICognitive Behavioral Therapy & InsomniaMajor Depressive Disorder

Quick Navigation

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

This is mechanistic clinical trial that evaluates the role of one of the glutamate receptors (mGluR5) in cognitive behavioral therapy for insomnia (CBT-I) as a common pathway in improving sleep and depression.

Official Title

Mechanistic Clinical Trial Evaluating the Role of the Metabotropic Glutamate Receptor Subtype 5 (mGluR5) in the Antidepressant Mechanism of Cognitive Behavioral Therapy for Insomnia (CBT-I)

Quick Facts

Study Start:2025-08-01
Study Completion:2030-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07076342

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * capacity to provide informed consent,
  2. * at least 18 years of age
  3. * good physical health and absence of significant medical conditions,
  4. * diagnosis of major depressive disorder (MDD) with current major depressive episode as per DSM-5 criteria
  5. * Montgomery-Åsberg Depression Rating Scale (MADRS) score \> 29 (at least moderate depression),
  6. * uniform range of sleep latencies up to 128 minutes.
  1. * currently taking effective antidepressants,
  2. * lifetime history of psychosis,
  3. * drug or alcohol dependence in the last 6 months or abuse in the last 2 months
  4. * unstable medical condition (i.e., condition not adequately stabilized for ≥ 3 months)
  5. * nicotine use within 1 year
  6. * currently on medication known to affect glutamate,
  7. * sleep disorders, other than insomnia, such as sleep apnea,
  8. * recent (within 1 year) regular night shift work (or rotating shift work) or recent (within 3 months) travel across more than one time zone, or plans for this work or travel during the study period,
  9. * use of medication or substances that affect sleep, for example, ingestion of more \> 600 mg of caffeine per day,
  10. * PET or MRI contraindications, including pregnancy or currently breastfeeding

Contacts and Locations

Study Contact

Wendy Zhang
CONTACT
(631)-638-2053
Wendy.Zhang@stonybrookmedicine.edu
Christine DeLorenzo, PhD
CONTACT
(631) 638-1523
christine.delorenzo@stonybrookmedicine.edu

Study Locations (Sites)

Stony Brook University: Dept of Psychiatry
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 Date2025-08-01
Study Completion Date2030-06

Study Record Updates

Study Start Date2025-08-01
Study Completion Date2030-06

Terms related to this study

Keywords Provided by Researchers

  • Cognitive Behavioral Therapy
  • CBT-I
  • Cognitive Behavioral Therapy & Insomnia
  • Major Depressive Disorder

Additional Relevant MeSH Terms

  • Major Depressive Disorder (MDD)