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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01583023
Recruitment Status : Unknown
Verified March 2014 by Pablo Cervantes, McGill University Health Centre/Research Institute of the McGill University Health Centre.
Recruitment status was:  Not yet recruiting
First Posted : April 23, 2012
Last Update Posted : April 1, 2014
Sponsor:
Information provided by (Responsible Party):
Pablo Cervantes, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date  ICMJE April 19, 2012
First Posted Date  ICMJE April 23, 2012
Last Update Posted Date April 1, 2014
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2014)
Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 8 weeks [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 6 weeks [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2014)
  • Change in Beck Depression Inventory (BDI-II) from baseline at 8 weeks [ Time Frame: 8 weeks ]
  • Change in Young Mania Rating Scale (YMRS) from baseline at 8 weeks [ Time Frame: 8 weeks ]
  • Alcohol use disorder identification test (AUDIT Assessment) [ Time Frame: At intake ]
  • Drug abuse screen test (DAST Assessment) [ Time Frame: At intake ]
  • Clinical Global Impression (CGI) & Analog scale [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
  • Change in Hamilton Depression Rating Scale (HAM-D 17) from baseline at 6 weeks [ Time Frame: 6 weeks ]
  • Change in Beck Depression Inventory (BDI-II) from baseline at 6 weeks [ Time Frame: 6 weeks ]
  • Change in Young Mania Rating Scale (YMRS) from baseline at 6 weeks [ Time Frame: 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Bipolar Depression
Official Title  ICMJE Assessing the Efficacy of Left Repetitive Transcranial Magnetic Stimulation (rTMS) as an Adjunctive Treatment to Mood Stabilizers for the Treatment of Bipolar Depression
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE
  • Drug: Bupropion
    150mg daily for first week, 300mg daily thereafter for a total of 8 weeks
    Other Name: 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.
  • Other: Placebo
    150mg daily first week, 300mg daily thereafter for a total of 8 weeks.
  • 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.
Study Arms  ICMJE
  • Experimental: Wellbutrin + Lithium a/o Epival + Sham rTMS
    Interventions:
    • Drug: Bupropion
    • Device: Sham repetitive transcranial magnetic stimulation
  • Experimental: Placebo + Lithium a/o Epival + Active rTMS
    Interventions:
    • Device: Active Repetitive Transcranial Magnetic Stimulation
    • Other: Placebo
  • Experimental: Wellbutrin + Lithium a/o Epival + Active rTMS
    Interventions:
    • Drug: Bupropion
    • Device: Active Repetitive Transcranial Magnetic Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 19, 2012)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2015
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01583023
Other Study ID Numbers  ICMJE RTMS-BD-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pablo Cervantes, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor  ICMJE McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP