Recruiting

mGluR5

Sponsor:

Stony Brook University

Code:

NCT07076342

Conditions

Major Depressive Disorder (MDD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy for Insomnia

PET Scan with [11C]ABP688

Study Details

Brief summary:

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.

Conditions

Major Depressive Disorder (MDD)

Study ID

NCT07076342

Start date

Aug 1, 2025

Status verified date

Aug, 2025

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • capacity to provide informed consent,
  • at least 18 years of age
  • good physical health and absence of significant medical conditions,
  • diagnosis of major depressive disorder (MDD) with current major depressive episode as per DSM-5 criteria
  • Montgomery-Åsberg Depression Rating Scale (MADRS) score > 29 (at least moderate depression),
  • uniform range of sleep latencies up to 128 minutes.

Exclusion Criteria:

  • currently taking effective antidepressants,
  • lifetime history of psychosis,
  • drug or alcohol dependence in the last 6 months or abuse in the last 2 months
  • unstable medical condition (i.e., condition not adequately stabilized for ≥ 3 months)
  • nicotine use within 1 year
  • currently on medication known to affect glutamate,
  • sleep disorders, other than insomnia, such as sleep apnea,
  • 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,
  • use of medication or substances that affect sleep, for example, ingestion of more > 600 mg of caffeine per day,
  • PET or MRI contraindications, including pregnancy or currently breastfeeding

Study Design

Enrollment

42 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive Behavioral Therapy for Insomnia Treatment Arm

Cognitive Behavioral Therapy for Insomnia (CBT-I) will be delivered through an online program, Sleep Healthy Using The Internet (SHUTi).

Interventions

Cognitive Behavioral Therapy for Insomnia

Cognitive Behavioral Therapy for Insomnia (CBT-I) will be delivered through an online program, Sleep Healthy Using The Internet Sleep Healthy Using The Internet (SHUTi)

PET Scan with [11C]ABP688

Prior to and after completing the CBT-I protocol, participants will undergo a PET scan using tracer \[11C\]ABP688) to quantify hippocampal mGluR5 density.

Primary outcome measure

  • Change in Sleep Latency from Baseline to 8 Weeks [ Time Frame: Baseline and 8 Weeks ]
  • Change from Baseline of mGluR5 density in the hippocampus after 8 weeks of CBT-I Treatment [ Time Frame: Baseline and 8 weeks ]

Central Contacts and Locations

Central contacts

Wendy Zhang

(631)-638-2053Wendy.Zhang@stonybrookmedicine.edu

Christine DeLorenzo, PhD

(631) 638-1523christine.delorenzo@stonybrookmedicine.edu

Locations

Stony Brook University: Dept of Psychiatry

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Christine DeLorenzo, PhD

(631) 638-1523Christine.DeLorenzo@stonybrookmedicine.edu

More Information

Sponsor

Stony Brook University

Last update posted

Feb 17, 2026

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2026-02-17.