mGluR5 and sleep-focused CBT for depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a mechanistic, interventional Phase 4 trial in adults with a current major depressive episode and significant insomnia. Participants will complete baseline and post-treatment PET imaging using [11C]ABP688 to quantify hippocampal mGluR5 density and will have overnight polysomnography to measure sleep latency. CBT-I will be delivered remotely via the SHUTi online program, and changes in mGluR5 and sleep will be compared before and after the intervention. Key exclusions include current effective antidepressant use, psychosis history, recent substance dependence, nicotine use within one year, other sleep disorders, and medications known to affect glutamate.

Why it matters

Who can join: the full rules

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's running

• Stony Brook University: Dept of Psychiatry
  Stony Brook, New York, United States Recruiting

Study contacts

• Study coordinator: Wendy Zhang
• Email: Wendy.Zhang@stonybrookmedicine.edu
• Phone: (631)-638-2053

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.