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Taking people in United StatesPhase 4

Studies a brain receptor in insomnia therapy for depression

Tests how a brain receptor relates to insomnia therapy in adults with depression.

Key facts

Who runs it
Stony Brook University
Where
Stony Brook, United StatesSee the site
Trial code
Registry title
The Role of mGluR5 in CBT-I
Status
Recruiting
Phase
Phase 4
People taking part
42 people, planned
Started
1 Aug 2025
Expected to end
31 Mar 2030
Type of study
Interventional
Treatments tested
  • Cognitive Behavioral Therapy for Insomnia
  • PET Scan with [11C]ABP688
Record updated
10 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with major depression and insomnia who are in good physical health. It studies how a brain receptor (mGluR5) is involved when CBT-I improves sleep and mood.

Age
18 years or older
Sex
All sexes can join
Disease stage
Major depressive disorder with a current major depressive episode (DSM-5), MADRS score above 29 (at least moderate depression), and sleep latencies up to 128 minutes
Earlier treatment
Cannot be taking effective antidepressants now, or medication known to affect glutamate

Main reasons for not taking part

  • Lifetime history of psychosis
  • Drug or alcohol dependence in the last 6 months, or abuse in the last 2 months
  • Sleep disorders other than insomnia, such as sleep apnea
  • Nicotine use within 1 year
  • PET or MRI contraindications, including pregnancy or breastfeeding

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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,
  • 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,
  • 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

Where in United States

  • Stony Brook University: Dept of PsychiatryStony Brook, United StatesContact: Christine DeLorenzo, PhDTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Cognitive Behavioral Therapy for Insomnia Treatment ArmTreatment being tested

    Cognitive Behavioral Therapy for Insomnia (CBT-I) will be delivered through an online program, Sleep Healthy Using The Internet (SHUTi).

    Treatment: Cognitive Behavioral Therapy for Insomnia and PET Scan with [11C]ABP688

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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)
Plain-language title
Studies a brain receptor in insomnia therapy for depressionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
10 November 2026