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Brain scans reveal how insomnia treatment may lift depression

NCT ID NCT07076342

Knowledge-focused Sponsor: Stony Brook University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how cognitive behavioral therapy for insomnia (CBT-I) changes a specific brain receptor (mGluR5) in people with major depression. 42 adults with depression and insomnia will receive online CBT-I and undergo PET brain scans before and after treatment. The goal is to understand the brain chemistry link between better sleep and improved mood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cognitive Behavioral Therapy for Insomnia (CBT-I) and PET scan tracer [11C]ABP688
What this could lead to
If successful, this could reveal a brain mechanism explaining why improving sleep helps depression, potentially guiding new treatments.
What could go wrong
This is a small, early-phase mechanistic study with only 42 participants, so results may not apply widely. It aims to understand biology, not test a new therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

insomnia major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder (MDD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Stony Brook University: Dept of Psychiatry

    RECRUITING

    Stony Brook, New York, 11794, United States

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