Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study

Depressive Disorder Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation Trajectory of Outcomes Study in Major Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04376697
• Other study ID #: 18-6253.1
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: December 2021

Study information

• Verified date: December 2020
• Source: University Health Network, Toronto
• Contact: Jonathan Downar, MD, PhD
• Phone: ?(647) 981-3951?
• Email: jonathan.downar[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation (rTMS)
The treatment will be delivered by trained medical personnel.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (week prior to treatment), on each treatment day, 1 week and 4 weeks post-treatment
Secondary	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.	Baseline (week prior to treatment) and after 1 week and 4 weeks post-treatment