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

This study is not yet open for participant recruitment.
Verified April 2012 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
Pablo Cervantes, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01583023
First received: April 19, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted

April 19, 2012
April 19, 2012
June 2012
May 2013   (final data collection date for primary outcome measure)
Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • Change in Hamilton Depression Rating Scale (HAM-D 17) from baseline at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Change in Beck Depression Inventory (BDI-II) from baseline at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Change in Young Mania Rating Scale (YMRS) from baseline at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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 Antidepressants 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 lithium and bupropion.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Bupropion
    150mg daily for first week, 300mg daily thereafter for a total of 6 weeks
    Other Name: Wellbutrin
  • Device: 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 6 weeks.
  • Experimental: Wellbutrin alone
    Intervention: Drug: Bupropion
  • Experimental: Placebo + rTMS
    Interventions:
    • Device: Repetitive Transcranial Magnetic Stimulation
    • Other: Placebo
  • Experimental: Wellbutrin + rTMS
    Interventions:
    • Drug: Bupropion
    • Device: Repetitive Transcranial Magnetic Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
45
September 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Bipolar Disorder Type I or II subjects diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) in depressed phase
  • Age 18 to 65
  • Rating on the Montgomery-Asberg Depression Rating Scale (MADRS) score > 20
  • Rating on the Hamilton Rating Scale for Depression (HAMD-17) > 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, subject must spend at least 4 weeks at a therapeutic dose before entering the study
  • Lithium monotherapy at a target dose of at least 0.7 mEq/L
  • If on psychotherapy, no less than 20 sessions in the last 6 months before initiation of rTMS

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
  • 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 a dose less than or equal to 1mg/day; Lorazepam is not allowed) and hypnotics
  • Previous treatment with Wellbutrin
  • Abnormal lab workup results
  • Subject currently enrolled in any detoxification program
Both
18 Years to 65 Years
No
Contact: Pablo Cervantes, MD 514-934-1934 ext 36109
Canada
 
NCT01583023
RTMS-BD-1
No
Pablo Cervantes, McGill University Health Center
McGill University Health Center
Not Provided
Principal Investigator: Pablo Cervanes, MD McGill University Health Center
Principal Investigator: Theodore Kolivakis, MD McGill University Health Center
Principal Investigator: Nancy CP Low, MD McGill University Health Center
McGill University Health Center
April 2012

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