Recruiting

TMS

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05813093

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

Interventions

rTMS

Study Details

Brief summary:

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

Major Depressive Disorder

Study ID

NCT05813093

Start date

Sep 27, 2023

Status verified date

Nov, 2024

Completion date

Jul 7, 2025

Anticipated

Primary completion date

Jul 7, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Age 20-65
  • Have a diagnosis of MDD or persistent depressive disorder and meet criteria for a major depressive episode (moderate-severe) according to the DSM 5.0 with a 17-item Hamilton Rating Scale Score in Depression (HRSD-17) of >=18
  • UTRD subjects will also have a duration of depressive symptoms >=5 years, treatment resistance to antidepressants will be defined by Maudsley-staging, failing >6 antidepressants (level 4) and >1 adjunctive antidepressants of adequate dose/duration, failed at >=1 psychotherapy, and no response to >=1 trial of esketamine, IV ketamine, ECT or rTMS
  • Milder TRD participants will have failed at least 1 antidepressant medication of adequate dose/duration and never had neuromodulation treatment

Exclusion criteria:

  • Contraindications to MRI
  • Medical/psychiatric co-morbidities that prevent participation in the study or where depression is not the primary psychiatric symptom of concern
  • History of psychosis, pregnancy, substance dependence within the last 6 months
  • Active neurological disorder
  • History of seizure disorder
  • Cognitive impairment
  • Unable to provide informed consent on their own
  • Pregnant

Study Design

Enrollment

88 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Accelerated iTBS treatment

accelerated iTBS treatment protocol over 5 consecutive days

Interventions

rTMS

Accelerated iTBS treatment

Primary outcome measure

  • Change in depressive symptomatology [ Time Frame: 3 years ]
  • Imaging [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Anusha Baskaran, PhD

416-480-6100anusha.baskaran@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

aNUSHA Basakran, PhD

416-480-6100anusha.baskaran@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Nov 15, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2024-11-15.