NCT07076342RecruitingPhase 4
The Role of mGluR5 in CBT-I
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)
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 14 Jul 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Mar 2030
- Lead sponsor
- Stony Brook University
- Diseases
- Depression
- NCT number
- NCT07076342
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 42
- From 1 Aug 2025 to the primary completion date, 31 Mar 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- currently taking effective antidepressants,
- drug or alcohol dependence in the last 6 months or abuse in the last 2 months
- currently on medication known to affect glutamate,
- use of medication or substances that affect sleep, for example, ingestion of more \> 600 mg of caffeine per day,
Other illness
- lifetime history of psychosis,
- unstable medical condition (i.e., condition not adequately stabilized for ≥ 3 months)
- sleep disorders, other than insomnia, such as sleep apnea,
Other
- nicotine use within 1 year
- 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,
- PET or MRI contraindications, including pregnancy or currently breastfeeding
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stony Brook University: Dept of Psychiatry Coordinator of this site? Confirm its status | Stony Brook | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.