Recruiting

TMS

Sponsor:

University Health Network, Toronto

Code:

NCT04376697

Conditions

Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Details

Brief summary:

This prospective, single-arm, open-label feasibility study will assess the safety, tolerability, and effectiveness of repetitive transcranial magnetic stimulation (rTMS) in patients with major depression (MDD) to test the hypothesis that remission rates can be increased by additional treatment sessions.

Conditions

Depressive Disorder

Study ID

NCT04376697

Start date

Mar 18, 2019

Status verified date

Dec, 2020

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • are outpatients
  • are voluntary and competent to consent to treatment
  • are between the ages of 18 and 85, inclusive
  • are able to adhere to the treatment schedule
  • pass the TMS safety-screening questionnaire
  • have had no change or initiation of any psychotropic medication in the 4 weeks prior to screening

Exclusion Criteria:

  • previous rTMS treatment
  • have a history of substance dependence or abuse within the last 3 months
  • have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
  • have active suicidal intent
  • have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
  • have a diagnosis of any psychotic disorder
  • have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure confirmed diagnostically by neurological assessment (except those therapeutically induced by ECT), cerebral aneurysm, Parkinson's disease, Huntington's chorea, dementia, stroke, neurologically confirmed diagnosis of traumatic brain injury, or multiple sclerosis.
  • if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
  • clinically significant laboratory abnormality, in the opinion of the investigator
  • currently (or in the last 4 weeks) take more than lorazepam 4 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
  • non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
  • any significant cardiovascular or metabolic disorder or insult including, but not limited to: coronary artery disease, abnormal heart rhythms, heart failure, cardiac valve disease, congenital heart disease, cardiomyopathy, vascular disease, dyslipidemia, diabetes, or hypertension

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active rTMS

Treatment will be delivered daily (weekdays) rTMS treatments, for up to 10 daily sessions and up to 75 sessions in total.

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

The treatment will be delivered by trained medical personnel.

Primary outcome measure

  • Beck Depression Inventory-II (BDI-II) (score 0-63, higher = more severe) [ Time Frame: Baseline (week prior to treatment), on each treatment day, 1 week and 4 weeks post-treatment ]

Central Contacts and Locations

Central contacts

Jonathan Downar, MD, PhD

‭(647) 981-3951‬jonathan.downar@uhn.ca

Eileen Lam

416-603-5800eileen.lam@uhn.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T2S8

Contacts

Eileen Lam

416-603-5800eileen.lam@uhn.ca

Principal Investigator:

Jonathan Downar, MD, PhD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 29, 2020

Last verified

Dec, 2020

Keywords

  • rTMS
  • TMS
  • repetitive transcranial magnetic stimulation
  • major depressive disorder
  • major depression
  • MDD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2020-12-29.