Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study in Major Depression

University Health Network, Toronto1 site in 1 country50 target enrollmentMarch 18, 2019

ConditionsDepressive Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Depressive Disorder
Sponsor: University Health Network, Toronto
Enrollment: 50
Locations: 1
Primary Endpoint: Beck Depression Inventory-II (BDI-II) (score 0-63, higher = more severe)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 18, 2019

End Date

December 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Health Network, Toronto

Responsible Party

Principal Investigator

Jonathan Downar

Clinician scientist

University Health Network, Toronto

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Outcome measured by a change in depression score at baseline, before every treatment, and at 1 and 4 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A score of 12 or less is categorized as remission.

Secondary Outcomes

Hamilton Depression Rating Scale 17-items (HDRS17) (score 0-52, higher = more severe)(Baseline (week prior to treatment) and after 1 week and 4 weeks post-treatment)