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

Primary Purpose

Bipolar Disorder

Status

Unknown status

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Bupropion

Active Repetitive Transcranial Magnetic Stimulation

Placebo

Sham repetitive transcranial magnetic stimulation

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring bipolar disorder, repetitive transcranial magnetic stimulation (rtms), bupropion, lithium a/o Epival

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Allan Memorial Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Wellbutrin + Lithium a/o Epival + Sham rTMS

Placebo + Lithium a/o Epival + Active rTMS

Wellbutrin + Lithium a/o Epival + Active rTMS

Arm Description

Outcomes

Primary Outcome Measures

Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 8 weeks

Secondary Outcome Measures

Change in Beck Depression Inventory (BDI-II) from baseline at 8 weeks

Change in Young Mania Rating Scale (YMRS) from baseline at 8 weeks

Alcohol use disorder identification test (AUDIT Assessment)

Drug abuse screen test (DAST Assessment)

Clinical Global Impression (CGI) & Analog scale

Full Information

NCT ID

NCT01583023

First Posted

April 19, 2012

Last Updated

March 31, 2014

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT01583023

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder

Keywords

bipolar disorder, repetitive transcranial magnetic stimulation (rtms), bupropion, lithium a/o Epival

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Wellbutrin + Lithium a/o Epival + Sham rTMS

Arm Type

Experimental

Arm Title

Placebo + Lithium a/o Epival + Active rTMS

Arm Type

Experimental

Arm Title

Wellbutrin + Lithium a/o Epival + Active rTMS

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Bupropion

Other Intervention Name(s)

Wellbutrin

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Active Repetitive Transcranial Magnetic Stimulation

Intervention 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(s)

Placebo

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Sham repetitive transcranial magnetic stimulation

Intervention 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.

Primary Outcome Measure Information:

Title

Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 8 weeks

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Change in Beck Depression Inventory (BDI-II) from baseline at 8 weeks

Time Frame

8 weeks

Title

Change in Young Mania Rating Scale (YMRS) from baseline at 8 weeks

Time Frame

8 weeks

Title

Alcohol use disorder identification test (AUDIT Assessment)

Time Frame

At intake

Title

Drug abuse screen test (DAST Assessment)

Time Frame

At intake

Title

Clinical Global Impression (CGI) & Analog scale

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pablo Cervantes, MD

Phone

514-934-1934

Ext

36109

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pablo Cervanes, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Theodore Kolivakis, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nancy CP Low, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gabriella Gobbi, M.D

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Allan Memorial Institute

City

Montreal

State/Province

Quebec

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pablo Cervantes, MD

First Name & Middle Initial & Last Name & Degree

Theodore Kolivakis, MD

First Name & Middle Initial & Last Name & Degree

Nancy CP Low, MD

First Name & Middle Initial & Last Name & Degree

Alain Ptito, PhD

First Name & Middle Initial & Last Name & Degree

Gabriella Gobbi, MD

First Name & Middle Initial & Last Name & Degree

Maykel F.Ghabrash, MD

12. IPD Sharing Statement

Learn more about this trial

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

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