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

NCT01583023 | Unknown Phase 4

• 1 other identifier: RTMS-BD-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  8 weeks

Secondary Outcomes (5)

• 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

Study Arms (3)

Wellbutrin + Lithium a/o Epival + Sham rTMS

EXPERIMENTAL

Drug: Bupropion; Device: Sham repetitive transcranial magnetic stimulation

Placebo + Lithium a/o Epival + Active rTMS

EXPERIMENTAL

Device: Active Repetitive Transcranial Magnetic Stimulation; Other: Placebo

Wellbutrin + Lithium a/o Epival + Active rTMS

EXPERIMENTAL

Drug: Bupropion; Device: Active Repetitive Transcranial Magnetic Stimulation

Interventions

Bupropion DRUG

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

Also known as: Wellbutrin

Wellbutrin + Lithium a/o Epival + Active rTMS; Wellbutrin + Lithium a/o Epival + Sham rTMS

Active Repetitive Transcranial Magnetic Stimulation DEVICE

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.

Placebo + Lithium a/o Epival + Active rTMS; Wellbutrin + Lithium a/o Epival + Active rTMS

Placebo OTHER

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

Placebo + Lithium a/o Epival + Active rTMS

Sham repetitive transcranial magnetic stimulation DEVICE

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.

Wellbutrin + Lithium a/o Epival + Sham rTMS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Failure of previous Wellbutrin treatment. Mood disorder secondary to a medical condition. Subject currently enrolled in any detoxification program

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Allan Memorial Institute

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo Cervantes, MD

CONTACT

514-934-1934

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Mood Disorders Clinic

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 23, 2012
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 1, 2014

Record last verified: 2014-03

Locations

CA (1)