NCT07091643Not yet recruiting
Neuroimaging Markers of Midlife Depression and Cognitive Behavioural Therapy (CBT)
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
Major depressive disorder (MDD) is associated with significant cognitive impairment throughout the life-course, which may progress toward MCI and dementia with age. Antidepressant medications are the first line of treatment; however, they fail to adequately address cognitive deficits and prevent relapse. Sustained cognitive impairment into euthymic periods may relate to underlying neurobiological changes, which could potentially be addressed through Cognitive Behavioural Therapy (CBT). Notably, CBT has been shown to improve cognitive domains including divided attention, memory, and processing speed while preventing depression relapse. Midlife represents a critical period in which shared neurobiological factors (such as brain changes on a vascular, morphological, and functional level) underlying depression and cognitive impairment could accelerate toward MCI and dementia. An updated understanding of neurobiological correlates of midlife depression and CBT response through multimodal neuroimaging is critical to improving affective and cognitive outcomes in this population. The overarching objective of this project is to use multimodal neuroimaging to quantify the neurobiological and clinical impact of CBT in midlife depression. Specifically, we aim to: 1. Investigate the clinical impact of CBT on cognitive function and mood outcomes in midlife depression 2. Examine functional connectivity and microstructural determinants of CBT response in midlife depression using neuroimaging 3. Identify vascular modulators of neural connectivity and CBT response in midlife depression. We hypothesize that midlife depression will be associated with functional and structural neural connectivity changes, which will be accompanied by vascular pathology. Adequate CBT response (i.e., improvements in mood and cognitive function) will be associated with amelioration of neurobiological changes.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Jul 2025
- Start date
- Jun 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Baycrest
- Diseases
- Depression
- NCT number
- NCT07091643
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Jun 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with electroconvulsive therapy, intravenous and/or intranasal ketamine in the 6-weeks prior to study enrolment.
- A history of traumatic brain injury, stroke, seizures, or previous brain surgery.
Other illness
- Presence of comorbid post-traumatic stress disorder, obsessive-compulsive disorder, eating disorder(s), schizophrenia, or other psychiatric disorders.
- History of a manic, hypomanic, or mixed depressive episode.
- History of substance-use disorder in the past 12 months.
- Presence of current alcohol-use disorder
- A history of major medical or neurological illness.
Other
- A positive urine toxicology screen for non-prescribed substance use.
- A positive pregnancy test at screening.
- Contraindications to magnetic resonance imaging (MRI) scanning.
Who the study is looking for
- Age 40-60 years, inclusive.
- Diagnosis of MDD as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)6 determined through a structured clinical interview.
- Current major depressive episode of at least 3 months in length.
- Depression of at least mild severity defined by a total score of ≥7 on the Montgomery Asberg Depression Rating Scale (MADRS)7.
- Ability to understand and comply with the requirements of the study, as judged by the investigator(s).
Age in the registry: 40 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baycrest Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.