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Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study

Primary Purpose

Depressive Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Repetitive Transcranial Magnetic Stimulation (rTMS)

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring rTMS, TMS, repetitive transcranial magnetic stimulation, major depressive disorder, major depression, MDD

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Toronto Western HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active rTMS

Arm Description

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

Outcomes

Primary Outcome Measures

Beck Depression Inventory-II (BDI-II) (score 0-63, higher = more severe)

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

Hamilton Depression Rating Scale 17-items (HDRS17) (score 0-52, higher = more severe)

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.

Full Information

NCT ID

NCT04376697

First Posted

April 25, 2020

Last Updated

December 26, 2020

Sponsor

University Health Network, Toronto

Collaborators

Centre for Addiction and Mental Health

1. Study Identification

Unique Protocol Identification Number

NCT04376697

Brief Title

Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study

Official Title

Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study in Major Depression

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 18, 2019 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Health Network, Toronto

Collaborators

Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depressive Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

prospective, single-arm, open label feasibility study

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active rTMS

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Description

The treatment will be delivered by trained medical personnel.

Primary Outcome Measure Information:

Title

Beck Depression Inventory-II (BDI-II) (score 0-63, higher = more severe)

Description

Time Frame

Baseline (week prior to treatment), on each treatment day, 1 week and 4 weeks post-treatment

Secondary Outcome Measure Information:

Title

Hamilton Depression Rating Scale 17-items (HDRS17) (score 0-52, higher = more severe)

Description

Time Frame

Baseline (week prior to treatment) and after 1 week and 4 weeks post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jonathan Downar, MD, PhD

Phone

‭(647) 981-3951‬

jonathan.downar@uhn.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Eileen Lam

Phone

416-603-5800

Ext

5494

eileen.lam@uhn.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Downar

Organizational Affiliation

University Health Network, Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toronto Western Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T2S8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eileen Lam

Phone

416-603-5800

Ext

5494

eileen.lam@uhn.ca

First Name & Middle Initial & Last Name & Degree

Jonathan Downar, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36055538

Citation

Sheen JZ, Miron JP, Mansouri F, Dunlop K, Russell T, Zhou R, Hyde M, Fox L, Voetterl H, Daskalakis ZJ, Griffiths JD, Blumberger DM, Downar J. Cardiovascular biomarkers of response to accelerated low frequency repetitive transcranial magnetic stimulation in major depression. J Affect Disord. 2022 Dec 1;318:167-174. doi: 10.1016/j.jad.2022.08.105. Epub 2022 Aug 31.

Results Reference

derived

PubMed Identifier

33581379

Citation

Miron JP, Voetterl H, Fox L, Hyde M, Mansouri F, Dees S, Zhou R, Sheen J, Desbeaumes Jodoin V, Mir-Moghtadaei A, Blumberger DM, Daskalakis ZJ, Vila-Rodriguez F, Downar J. Optimized repetitive transcranial magnetic stimulation techniques for the treatment of major depression: A proof of concept study. Psychiatry Res. 2021 Apr;298:113790. doi: 10.1016/j.psychres.2021.113790. Epub 2021 Feb 7.

Results Reference

derived

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Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study

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