The Role of mGluR5 in CBT-I

Официальное название

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)

Обзор

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.

Подробное описание

Cognitive behavioral therapy for insomnia (CBT-I), a treatment solely aimed at improving sleep, reduces depression with rates similar to conventional antidepressants. Although this efficacy reflects the interrelationship between sleep and depression, CBT-I's antidepressant mechanism of action is currently unknown. One potential mechanistic pathway is through the metabotropic glutamate receptor subtype 5 (mGluR5), due to its strong association with both depression and sleep. The investigators hypothesize that CBT-I's antidepressant efficacy may occur through the downregulation of mGluR5 associated with improved sleep. This study is a mechanistic clinical trial in a cohort of adults with MDD and a range of sleep latencies (time it takes to fall asleep). Prior to and following CBT-I, the investigators will quantify hippocampal mGluR5 density (with using positron emission tomography \[PET\] imaging) and sleep latency (with polysomnography performed in the Sleep Lab). CBT-I will be delivered through an online program, Sleep Healthy Using The Internet (SHUTi).

Вмешательства

• Поведенческое Cognitive Behavioral Therapy for Insomnia
  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)
• Препарат PET Scan with [11C]ABP688
  Prior to and after completing the CBT-I protocol, participants will undergo a PET scan using tracer \[11C\]ABP688) to quantify hippocampal mGluR5 density.

Первичные конечные точки

• Change in Sleep Latency from Baseline to 8 Weeks [Срок оценки: Baseline and 8 Weeks]
• Change from Baseline of mGluR5 density in the hippocampus after 8 weeks of CBT-I Treatment [Срок оценки: Baseline and 8 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Stony Brook University: Dept of Psychiatry — Stony Brook

Идентификаторы

NCT: NCT07076342 · 2025-00015 · 1R01MH137211-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗