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Can therapy reshape the depressed brain? new study aims to find out

NCT ID NCT07091643

Knowledge-focused Sponsor: Baycrest Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will use brain scans to see how cognitive behavioural therapy (CBT) affects the brains of 30 people aged 40-60 with major depression. Participants will receive 12 weeks of CBT, with follow-ups up to 9 months. The goal is to understand how CBT improves mood and thinking, and whether brain changes can be seen on MRI.

What this could mean

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

Active substance
Cognitive Behavioural Therapy (CBT)
What this could lead to
If successful, this could reveal how CBT changes the brain in midlife depression, pointing toward better treatments that target both mood and cognitive decline.
What could go wrong
This is a small, early-stage study (30 people) focused on brain imaging, not a treatment trial. Results may not apply to everyone, and the therapy may not work for all participants.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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

40 to 60 years

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: 1. Age 40-60 years, inclusive. 2. Diagnosis of MDD as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)6 determined through a structured clinical interview. 3. Current major depressive episode of at least 3 months in length. 4. Depression of at least mild severity defined by a total score of ≥7 on the Montgomery Asberg Depression Rating Scale (MADRS)7. 5. Ability to understand and comply with the requirements of the study, as judged by the investigator(s). Exclusion Criteria: 1. Presence of comorbid post-traumatic stress disorder, obsessive-compulsive disorder, eating disorder(s), schizophrenia, or other psychiatric disorders. 2. History of a manic, hypomanic, or mixed depressive episode. 3. Treatment with electroconvulsive therapy, intravenous and/or intranasal ketamine in the 6-weeks prior to study enrolment. 4. History of substance-use disorder in the past 12 months. 5. Presence of current alcohol-use disorder 6. A positive urine toxicology screen for non-prescribed substance use. 7. A positive pregnancy test at screening. 8. A history of major medical or neurological illness. 9. A history of traumatic brain injury, stroke, seizures, or previous brain surgery. 10. Contraindications to magnetic resonance imaging (MRI) scanning.

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Conditions

The condition(s) this trial relates to.

Depression 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

  • Baycrest Hospital

    Toronto, Ontario, M6A 2E1, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.