Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06163625

The Impact of Working Memory and Reward Markers on DLPFC Activity in Treatment-resistant Depression

Led by Unity Health Toronto · Updated on 2024-12-19

50

Participants Needed

1

Research Sites

104 weeks

Total Duration

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AI-Summary

What this Trial Is About

Major Depressive Disorder (MDD) is a very common illness that is usually treated with antidepressant medication. Depression can be caused by many things such as childhood experiences, genetics, and changes in the way the body and brain function. For those with depression where medication and psychotherapy have limited benefit, repetitive transcranial magnetic stimulation (rTMS) is an effective treatment. rTMS is a treatment that involves stimulating certain areas of the brain with magnetic field pulses. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region. This can be helpful in treating some kinds of psychiatric and neurological disorder, including MDD. It is not fully known how rTMS changes brain activity to improve symptoms of depression. However, certain brain areas responsible for behaviours impacted by depression are underactive in those with depression. One of those brain regions called the dorsolateral prefrontal cortex (DLPFC), and the investigators will target this region using rTMS. By increasing the activity of these regions, rTMS could potentially improve depression symptoms. For participants receiving rTMS, the investigators will be using the participant's brain scan to better understand brain activity of the brain region stimulated by rTMS before and after treatment. In this study, the investigators will be collecting detailed information about participants' psychiatric history and depression symptoms, as well as brain scans and saliva samples. The saliva samples will undergo proteomic (having to do with proteins) analyses to identify biological markers ("biomarkers": biological features (e.g.: gene, protein) that can be measured to indicate factors related to rTMS response. The investigators' goal is to use this information to help us understand whether improvement to rTMS depends on brain activity or proteomic factors localized to two specific behaviours impacted by depression: reward processing and working memory (the capacity to hold information temporarily, such as holding a person's address in mind while listening to instructions about how to get there).

CONDITIONS

Official Title

The Impact of Working Memory and Reward Markers on DLPFC Activity in Treatment-resistant Depression

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 65 years old
  • Able to give voluntary and informed consent
  • Fluent in English
  • For depressed participants: diagnosed with major depressive disorder using the Mini-International Neuropsychiatric Interview
  • For depressed participants: have moderate to severe depression with a Hamilton Depression Rating Scale score of 18 or higher
  • For depressed participants: inadequate response to an adequate dose of antidepressants or intolerance to at least two antidepressant trials
  • No changes in psychotropic medication in the four weeks before screening
  • If in psychotherapy, must have had stable treatment for at least three months with no planned changes
  • Able to follow the study schedule
  • For nondepressed participants: no current or past psychiatric diagnoses
  • For nondepressed participants: low depression severity with a Hamilton Depression Rating Scale score less than 8
  • For nondepressed participants: no history of antidepressant use
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Acute suicidality with a high score on the Hamilton Depression Rating Scale item #3
  • Bipolar disorder or other primary psychiatric disorders more severe than depression
  • Serious medical conditions needing immediate treatment, pacemaker, or implanted medication pump
  • History of psychosis or current psychotic symptoms
  • Drug abuse or dependence within the last six months (excluding caffeine and nicotine)
  • Contraindications for rTMS such as history of seizures, cochlear implants, high-dose benzodiazepine use, pacemaker, implanted neurostimulator, or serious head trauma
  • Electroconvulsive therapy during the current depressive episode
  • Contraindications for MRI including metallic implants
  • Significant neurological disorders such as increased intracranial pressure, brain lesions, seizure history (except ECT induced), cerebral aneurysm, Parkinson's, Huntington's, multiple sclerosis, dementia, or serious head trauma with loss of consciousness for 5 minutes or more

AI-Screening

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Trial Site Locations

Total: 1 location

1

Unity Health Toronto

Toronto, Ontario, Canada, M5B1M8

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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