Actively Recruiting

Phase Not Applicable
Age: 20Years - 65Years
All Genders
NCT05813093

Interleaved TMS-fMRI in Ultra-treatment Resistant Depression

Led by Sunnybrook Health Sciences Centre · Updated on 2024-11-15

88

Participants Needed

1

Research Sites

92 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a study that will recruit patients from the neurosurgery clinic and the regular TMS clinic. It's a smaller study designed to collect brain imaging pre-treatment and then use image guided TMS to treat patient with a one week "accelerated" rTMS protocol using the research TMS machine that is housed in Dr. Sean Nestor's lab. The idea is to examine whether severe treatment resistant depression has a different brain signature than less severe/TRD and whether the investigators can get a therapeutic response from patients that would otherwise undergo neurosurgery or will ultimately undergo neurosurgery.

CONDITIONS

Official Title

Interleaved TMS-fMRI in Ultra-treatment Resistant Depression

Who Can Participate

Age: 20Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 20 and 65 years
  • Diagnosis of major depressive disorder or persistent depressive disorder with a moderate to severe major depressive episode confirmed by DSM 5.0
  • Hamilton Rating Scale for Depression (HRSD-17) score of 18 or higher
  • For ultra-treatment resistant depression (UTRD) group: depressive symptoms lasting 5 years or longer, resistance to more than 6 antidepressants and at least 1 adjunctive medication, failed at least 1 psychotherapy, and no response to at least 1 trial of esketamine, IV ketamine, ECT, or rTMS
  • For milder treatment resistant depression (TRD) group: failure of at least 1 antidepressant medication of adequate dose and duration, and no prior neuromodulation treatment
Not Eligible

You will not qualify if you...

  • Contraindications to MRI
  • Medical or psychiatric conditions that prevent study participation or where depression is not the main psychiatric issue
  • History of psychosis
  • Pregnancy
  • Substance dependence in the past 6 months
  • Active neurological disorders
  • History of seizure disorder
  • Cognitive impairment
  • Unable to provide informed consent independently

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N3M5

Actively Recruiting

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Research Team

A

Anusha Baskaran, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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