The Role of mGluR5 in CBT-I

ConditionMajor Depressive Disorder (MDD)

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorStony Brook University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

Cognitive Behavioral Therapy for Insomnia
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
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.

Treatment groups

42 Participants

are divided into 1 treatment group

Group A: Cognitive Behavioral Therapy for Insomnia Treatment ArmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Change in Sleep Latency from Baseline to 8 Weeks

Polysomnography: Prior to and following CBT-I, participants will spend one or two nights in the facility's Sleep Lab in order to assess sleep latency (i.e., quantity of sleep). While the participant sleeps, polysomnography, including EEG will be collected. This will be used to quantify sleep latency.

Time frame

Baseline and 8 Weeks

Change from Baseline of mGluR5 density in the hippocampus after 8 weeks of CBT-I Treatment

PET Imaging: Prior to and following CBT-I, participants will receive PET imaging to allow measurement of change in mGluR5 (a protein receptor in the brain) density in the hippocampus.

Time frame

Baseline and 8 weeks

Sponsors and contacts

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Stony Brook University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

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