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Antidepressant
Using Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Bipolar Depression
Phase 4
Waitlist Available
Led By Theodore Kolivakis, MD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
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 up to 5 years
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
Summary
The purpose of this study is to evaluate whether repetitive transcranial magnetic stimulation (rTMS) treatment is an effective adjunct treatment to mood stabilizers and Bupropion.
Eligible Conditions
- Bipolar Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Wellbutrin + Lithium a/o Epival + Sham rTMSExperimental Treatment2 Interventions
Group II: Wellbutrin + Lithium a/o Epival + Active rTMSExperimental Treatment2 Interventions
Group III: Placebo + Lithium a/o Epival + Active rTMSExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham repetitive transcranial magnetic stimulation
2018
Completed Phase 2
~490
Active Repetitive Transcranial Magnetic Stimulation
2010
N/A
~20
Bupropion
FDA approved
Find a Location
Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
471 Previous Clinical Trials
166,962 Total Patients Enrolled
Theodore Kolivakis, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
Nancy CP Low, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
Gabriella Gobbi, M.DPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
Pablo Cervanes, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre