Using Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Bipolar Depression
NCT ID: NCT01583023
Last Updated: 2014-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
45 participants
INTERVENTIONAL
2014-04-30
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Wellbutrin + Lithium a/o Epival + Sham rTMS
Bupropion
150mg daily for first week, 300mg daily thereafter for a total of 8 weeks
Sham repetitive transcranial magnetic stimulation
Sham rTMS will also begin their treatment 5 times a week for 4 weeks in junction with pharmacotherapy (Wellbutrin). Sham rTMS will be delivered at a frequency of 10 Hz and stimulation will be applied in 5-second trains with a 20-second inter-train interval, for 30 trains per session.
Placebo + Lithium a/o Epival + Active rTMS
Active Repetitive Transcranial Magnetic Stimulation
Daily left DLPFC, at 110% motor threshold, with a frequency of 10 Hz. Stimulation will be applied in 5-second trains with a 10-second inter-train interval, for 30 trains per session. This treatment will be provided for the first 4 weeks of the study.
Placebo
150mg daily first week, 300mg daily thereafter for a total of 8 weeks.
Wellbutrin + Lithium a/o Epival + Active rTMS
Bupropion
150mg daily for first week, 300mg daily thereafter for a total of 8 weeks
Active Repetitive Transcranial Magnetic Stimulation
Daily left DLPFC, at 110% motor threshold, with a frequency of 10 Hz. Stimulation will be applied in 5-second trains with a 10-second inter-train interval, for 30 trains per session. This treatment will be provided for the first 4 weeks of the study.
Interventions
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Bupropion
150mg daily for first week, 300mg daily thereafter for a total of 8 weeks
Active Repetitive Transcranial Magnetic Stimulation
Daily left DLPFC, at 110% motor threshold, with a frequency of 10 Hz. Stimulation will be applied in 5-second trains with a 10-second inter-train interval, for 30 trains per session. This treatment will be provided for the first 4 weeks of the study.
Placebo
150mg daily first week, 300mg daily thereafter for a total of 8 weeks.
Sham repetitive transcranial magnetic stimulation
Sham rTMS will also begin their treatment 5 times a week for 4 weeks in junction with pharmacotherapy (Wellbutrin). Sham rTMS will be delivered at a frequency of 10 Hz and stimulation will be applied in 5-second trains with a 20-second inter-train interval, for 30 trains per session.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Age 18 to 70. Rating on the Montgomery-Asberg Depression Rating Scale (MADRS) score \> 20. Rating on the Beck Depression Inventory (BDI-II) \> 20. Rating on the Young Mania Rating Scale (YMRS) \< 8. Non-treated new depressive episode, at least 2 weeks in duration. If recently started on an antidepressant other than Wellbutrin, subject must spend at least 4 weeks at a therapeutic dose before entering the study.
Lithium and epival (Sodium Valproate) in monotherapy or in combination. Novel antipsychotics can be combined with mood stabilizers for at least 4 weeks at a steady dosage prior to the study.
Failure of previous Wellbutrin treatment. Mood disorder secondary to a medical condition. Subject currently enrolled in any detoxification program
18 Years
70 Years
ALL
No
Sponsors
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McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER
Responsible Party
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Pablo Cervantes
Director of the Mood Disorders Clinic
Principal Investigators
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Pablo Cervanes, MD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Theodore Kolivakis, MD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Nancy CP Low, MD
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Gabriella Gobbi, M.D
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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Allan Memorial Institute
Montreal, Quebec, Canada
Countries
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Central Contacts
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Pablo Cervantes, MD
Role: CONTACT
Other Identifiers
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RTMS-BD-1
Identifier Type: -
Identifier Source: org_study_id
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