What this study is
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.
What's being tested
- Cognitive Behavioral Therapy for Insomnia
Intervention · 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
Intervention · 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.
Study details
- 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)
- Sponsor
- Stony Brook University
- Conditions
- Major Depressive Disorder (MDD)
- Enrolling
- 42 people
- Starts
- 2025-08-01
- Est. completion
- 2030-03-31
- Design
- Open-label, single group, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openStony Brook University: Dept of Psychiatry
Stony Brook, New York, United States
- Christine DeLorenzo, PhD · Contact(631) 638-1523Christine.DeLorenzo@stonybrookmedicine.edu
Recruiting
Study team
Sponsor
Stony Brook University
Study ID 2025-00015
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.