Using Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Bipolar Depression
- Conditions
- Bipolar Disorder
- Interventions
- Device: Active Repetitive Transcranial Magnetic StimulationOther: PlaceboDevice: Sham repetitive transcranial magnetic stimulation
- Registration Number
- NCT01583023
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
BD Type I or II subjects diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) in depressed phase.
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.
History of any DSM-IV Axis I diagnosis other than BD Type I or II Presence of any psychotic symptoms, characterized by a score of 3 or more on item 10 of the MADRS, a score of 6 on item 9 of the MADRS, or a score of 6 or more on item 8 of the YMRS Comorbid active dependence or substance abuse (except nicotine) Prior electroconvulsive therapy failure Pacemaker, automatic implantable defibrillator or implantable pump Aneurysm Clip Heart/Vascular Clip Prosthetic Valve Metal Prosthesis Pregnancy (must do a blood β-HCG test to exclude) Metal or metal fragments in the head Personal or Family history of seizure disorder Increased Intracranial pressure History of stroke, meningitis/encephalitis, moderate to severe traumatic brain injury, neurosurgical procedure Pharmacotherapy using any substances not mentioned in the inclusion criteria, except benzodiazepines at an equivalent dose of less than or equal to 1mg/day of lorazepam.
Failure of previous Wellbutrin treatment. Mood disorder secondary to a medical condition. Subject currently enrolled in any detoxification program
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + Lithium a/o Epival + Active rTMS Placebo - Wellbutrin + Lithium a/o Epival + Sham rTMS Bupropion - Wellbutrin + Lithium a/o Epival + Sham rTMS Sham repetitive transcranial magnetic stimulation - Wellbutrin + Lithium a/o Epival + Active rTMS Bupropion - Placebo + Lithium a/o Epival + Active rTMS Active Repetitive Transcranial Magnetic Stimulation - Wellbutrin + Lithium a/o Epival + Active rTMS Active Repetitive Transcranial Magnetic Stimulation -
- Primary Outcome Measures
Name Time Method Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 8 weeks 8 weeks
- Secondary Outcome Measures
Name Time Method Change in Beck Depression Inventory (BDI-II) from baseline at 8 weeks 8 weeks Change in Young Mania Rating Scale (YMRS) from baseline at 8 weeks 8 weeks Alcohol use disorder identification test (AUDIT Assessment) At intake Drug abuse screen test (DAST Assessment) At intake Clinical Global Impression (CGI) & Analog scale 8 weeks
Trial Locations
- Locations (1)
Allan Memorial Institute
🇨🇦Montreal, Quebec, Canada