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

March 31, 2014 updated by: Pablo Cervantes, McGill University Health Centre/Research Institute of the McGill University Health Centre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Allan Memorial Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wellbutrin + Lithium a/o Epival + Sham rTMS
Drug: Bupropion
150mg daily for first week, 300mg daily thereafter for a total of 8 weeks
Other Names:
  • Wellbutrin
Device: 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.
Experimental: Placebo + Lithium a/o Epival + Active rTMS
Device: 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.
Other: Placebo
150mg daily first week, 300mg daily thereafter for a total of 8 weeks.
Experimental: Wellbutrin + Lithium a/o Epival + Active rTMS
Drug: Bupropion
150mg daily for first week, 300mg daily thereafter for a total of 8 weeks
Other Names:
  • Wellbutrin
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 8 weeks
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Beck Depression Inventory (BDI-II) from baseline at 8 weeks
Time Frame: 8 weeks
8 weeks
Change in Young Mania Rating Scale (YMRS) from baseline at 8 weeks
Time Frame: 8 weeks
8 weeks
Alcohol use disorder identification test (AUDIT Assessment)
Time Frame: At intake
At intake
Drug abuse screen test (DAST Assessment)
Time Frame: At intake
At intake
Clinical Global Impression (CGI) & Analog scale
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: Pablo Cervanes, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Principal Investigator: Theodore Kolivakis, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Principal Investigator: Nancy CP Low, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Principal Investigator: Gabriella Gobbi, M.D, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

April 1, 2015

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

April 19, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimate)

April 23, 2012

Study Record Updates

Last Update Posted (Estimate)

April 1, 2014

Last Update Submitted That Met QC Criteria

March 31, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTMS-BD-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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