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Procedure

MagPro X100 Stimulator, B70 Fluid-Cooled Coil for Depression, Bipolar Disorder

N/A
Waitlist Available
Led By Daniel Blumberger, MD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks (tapering and relapse prevention phase)
Awards & highlights

Study Summary

This trial is testing a new, high-dose protocol for treating bipolar depression, which may be especially helpful during the COVID-19 pandemic.

Eligible Conditions
  • Depression, Bipolar Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks (tapering and relapse prevention phase)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks (tapering and relapse prevention phase) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
Secondary outcome measures
Change in General Anxiety Disorder 7 item (GAD-7)
Change in Hamilton Rating Scale for Depresion 24-it (HRSD-24)
Change in Patient Health Questionnaire (PHQ-9)
+13 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Accelerated LFRExperimental Treatment1 Intervention
In the acute treatment phase, treatment will occur 8 times daily (50 min pause between treatments) on weekdays, until symptom remission is achieved (HRSD-24 score < to 10) or a maximum of 10 working days of daily treatment. In the tapering phase, treatments will be reduced to 2 treatment days per week for 2 weeks and then 1 treatment day per week for 2 weeks (4 weeks total). Patients that have responded to treatment will then enter the symptom-based relapse prevention phase including virtual check-in with study staff and a treatment schedule based on symptom level according to a modified relapse prevention algorithm that has been developed to prevent relapse after a successful course of ECT (known as the STABLE algorithm). The relapse prevention phase will last a maximum of 6 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MagPro X100 Stimulator, B70 Fluid-Cooled Coil
2020
N/A
~210

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
356 Previous Clinical Trials
81,429 Total Patients Enrolled
Daniel Blumberger, MDPrincipal InvestigatorCAMH
4 Previous Clinical Trials
663 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Accelerated LFR for Bipolar Patients During the COVID-19 Pandemic
Daniel Blumberger 2020. "Accelerated LFR for Bipolar Patients During the COVID-19 Pandemic". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04427137.
~6 spots leftby Apr 2025
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