The Role of mGluR5 in CBT-I
Recruiting · NCT07076342 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Cognitive Behavioral Therapy for InsomniaPET Scan with [11C]ABP688
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Stony Brook University: Dept of Psychiatry - Stony Brook, New York, United States