Recruiting
The Role of mGluR5 in CBT-I
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.
ClinicalTrials.gov IDNCT07076342
PhasePHASE4
Enrollment42
SponsorStony Brook University
Age18 Years and older
SexALL
Conditions studied
Major Depressive Disorder (MDD)
About this study
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.
Interventions
- Behavioral: 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)
- Drug: 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 outcomes
- Change in Sleep Latency from Baseline to 8 Weeks (Baseline and 8 Weeks)
- Change from Baseline of mGluR5 density in the hippocampus after 8 weeks of CBT-I Treatment (Baseline and 8 weeks)
Eligibility information
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 locations
- Stony Brook University: Dept of Psychiatry, Stony Brook, New York 11794 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-20.