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

NCT01583023 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2014-04-01

No results posted yet for this study

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

Interventions

DRUG

Bupropion

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

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Pablo Cervanes, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Theodore Kolivakis, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Nancy CP Low, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Gabriella Gobbi, M.D · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01583023 on ClinicalTrials.gov