Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study

Not Applicable

• Conditions: Depressive Disorder
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

• Registration Number: NCT04376697
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-18
• Study First Submitted: 2020-04-25
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-06
• Status Verified: 2020-12
• Primary Completion: 2020-12
• Last Update Submitted: 2020-12-26
• Last Update Posted: 2020-12-29
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active rTMS	Repetitive Transcranial Magnetic Stimulation (rTMS)	Treatment will be delivered daily (weekdays) rTMS treatments, for up to 10 daily sessions and up to 75 sessions in total.

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory-II (BDI-II) (score 0-63, higher = more severe)	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 Outcome Measures

Name	Time	Method
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	Outcome measured by a change in depression score from baseline (week prior to treatment) to 1 week and 4 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A score of 7 or less is categorized as remission.

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada