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Antidepressant
Wellbutrin + Lithium a/o Epival + Sham rTMS for Bipolar Disorder
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 8 weeks
Awards & highlights
Study 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 ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 8 weeks
Secondary outcome measures
Alcohol use disorder identification test (AUDIT Assessment)
Change in Beck Depression Inventory (BDI-II) from baseline at 8 weeks
Change in Young Mania Rating Scale (YMRS) from baseline at 8 weeks
+2 moreTrial 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
447 Previous Clinical Trials
159,707 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
Frequently Asked Questions
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