The Role of mGluR5 in CBT-I
Major Depressive Disorder (MDD)
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Phase 4
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 42 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
Cognitive behavioral therapy for insomnia (CBT-I), a treatment solely aimed at improving sleep, reduces depression with rates similar to conventional antidepressants. Although this efficacy reflects the interrelationship between sleep and depression, CBT-I's antidepressant mechanism of action is currently unknown. One potential mechanistic pathway is through the metabotropic glutamate receptor subtype 5 (mGluR5), due to its strong association with both depression and sleep. The investigators hypothesize that CBT-I's antidepressant efficacy may occur through the downregulation of mGluR5 associated with improved sleep. This study is a mechanistic clinical trial in a cohort of adults with MDD and a range of sleep latencies (time it takes to fall asleep). Prior to and following CBT-I, the investigators will quantify hippocampal mGluR5 density (with using positron emission tomography \[PET\] imaging) and sleep latency (with polysomnography performed in the Sleep Lab). CBT-I will be delivered through an online program, Sleep Healthy Using The Internet (SHUTi).
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
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).
Behavioral: Cognitive Behavioral Therapy for Insomnia · Drug: PET Scan with [11C]ABP688
Cognitive Behavioral Therapy for Insomnia BEHAVIORAL
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 DRUG
Prior to and after completing the CBT-I protocol, participants will undergo a PET scan using tracer \[11C\]ABP688) to quantify hippocampal mGluR5 density.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Change in Sleep Latency from Baseline to 8 Weeks
Time frame: Baseline and 8 Weeks
Polysomnography: Prior to and following CBT-I, participants will spend one or two nights in the facility's Sleep Lab in order to assess sleep latency (i.e., quantity of sleep). While the participant sleeps, polysomnography, including EEG will be collected. This will be used to quantify sleep latency.
Change from Baseline of mGluR5 density in the hippocampus after 8 weeks of CBT-I Treatment
Time frame: Baseline and 8 weeks
PET Imaging: Prior to and following CBT-I, participants will receive PET imaging to allow measurement of change in mGluR5 (a protein receptor in the brain) density in the hippocampus.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Stony Brook University: Dept of PsychiatryStony Brook, New York, United StatesRecruiting
Study team and timeline
- Lead sponsor
- Stony Brook University
- Study start
- Aug 1, 2025 Actual
- Primary completion
- Mar 31, 2030 Estimated
- Study completion
- Mar 31, 2030 Estimated
- First posted
- Jul 22, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study 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)
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026