Using Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Bipolar Depression

Assessing the Efficacy of Left Repetitive Transcranial Magnetic Stimulation (rTMS) as an Adjunctive Treatment to Mood Stabilizers for the Treatment of Bipolar Depression

Sponsors

Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Source 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.

Overall Status Unknown status
Start Date 2014-04-01
Completion Date 2015-04-01
Primary Completion Date 2015-04-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 8 weeks 8 weeks
Secondary Outcome
Measure Time Frame
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
Enrollment 45
Condition
Intervention

Intervention Type: Drug

Intervention Name: Bupropion

Description: 150mg daily for first week, 300mg daily thereafter for a total of 8 weeks

Other Name: Wellbutrin

Intervention Type: Device

Intervention Name: Active Repetitive Transcranial Magnetic Stimulation

Description: 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.

Intervention Type: Other

Intervention Name: Placebo

Description: 150mg daily first week, 300mg daily thereafter for a total of 8 weeks.

Arm Group Label: Placebo + Lithium a/o Epival + Active rTMS

Intervention Type: Device

Intervention Name: Sham repetitive transcranial magnetic stimulation

Description: 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.

Arm Group Label: Wellbutrin + Lithium a/o Epival + Sham rTMS

Eligibility

Criteria:

Inclusion Criteria: 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. Exclusion Criteria: 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Overall Official
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Investigator: Allan Memorial Institute Pablo Cervantes, MD Principal Investigator Theodore Kolivakis, MD Principal Investigator Nancy CP Low, MD Principal Investigator Alain Ptito, PhD Sub-Investigator Gabriella Gobbi, MD Principal Investigator Maykel F.Ghabrash, MD Sub-Investigator
Location Countries

Canada

Verification Date

2014-03-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigator Full Name: Pablo Cervantes

Investigator Title: Director of the Mood Disorders Clinic

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Wellbutrin + Lithium a/o Epival + Sham rTMS

Type: Experimental

Label: Placebo + Lithium a/o Epival + Active rTMS

Type: Experimental

Label: Wellbutrin + Lithium a/o Epival + Active rTMS

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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