Efficacy of rTMS in Bipolar Depression

Last updated: January 17, 2025
Sponsor: University of British Columbia
Overall Status: Terminated

Phase

N/A

Condition

Depression (Major/severe)

Depression

Bipolar Disorder

Treatment

iTBS repetitive Transcranial Magnetic Stimulation (rTMS)

Sham rTMS

Clinical Study ID

NCT02749006
H16-00259
  • Ages 18-70
  • All Genders

Study Summary

Bipolar Disorder is a common condition that is characterized by periods of mood elevation however periods of chronic and recurring depressive episodes are more common and can be severely disabling. Effective treatments exist, however a significant portion of bipolar depressed patients do not respond to, or have difficulty tolerating many of these interventions. Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive neuromodulatory technique that is effective in major depression and there is evidence for its efficacy in bipolar depression which needs to be assessed in larger randomized controlled trials. This study is a randomised, double-blind, sham-controlled trial over four weeks. The primary objective is to assess improvement in depressive symptoms in acute bipolar depressed patients on treatment with intermittent Theta-Burst Stimulation (iTBS) in comparison to sham-rTMS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Are a male or female aged 18 to 70 years.

  • Have a diagnosis of Bipolar Disorder with a current ongoing episode of depression.

  • Are not currently experiencing a mania.

  • Have failed to achieve a clinical response or have been unable to tolerate anadequate dose of at least one of the medications used for treating Bipolardepression

  • Are taking an anti-manic agent (lithium or valproate) or an atypical antipsychotic (quetiapine, lurasidone, aripiprazole, ziprasidone, risperidone, olanzapine), or acombination of the above, or a combination of any of them with lamotrigine 100-400mg daily. Lamotrigine alone for bipolar II disorder is permitted.

  • current medications have been at a stable dose in the 2 weeks prior to randomization

  • Are capable of understanding, consenting to, and complying with the requirements ofthe study

Exclusion

Exclusion criteria:

  • Have an alcohol or substance abuse or dependence within the last 3 months.

  • Are at a significant risk of harm to themselves or others

  • Are pregnant or planning on becoming pregnant in near future or lactating.

  • Have a personal or family history of seizures.

  • Have a history of unstable or inadequately treated medical illnesses, includingmoderate to severe brain injury or head trauma.

  • Have a primary diagnosis of other psychiatric disorders (other than Bipolar) orpersonality disorders that are of primary concern and causing greater impairmentother than bipolar disorder.

  • are currently taking more than 3 of the antipsychotics.

  • Have failed a course of ECT in the current episode.

  • History of non-response to rTMS treatment.

  • If participating in psychotherapy, you must have been in stable treatment for atleast 3 months prior to entry into the study,

  • Currently (or in the last 4 weeks) taking more than 2 mg daily (or equivalent) oflorazepam or any dose of medication for seizures

  • Have a pacemaker, or an implant (e.g., aneurysm clips, shunts, stimulators, cochlearimplants, or electrodes) or any other metal object within or near the head,excluding the mouth that cannot be safely removed.

  • Have a non-correctable clinically significant sensory impairment (i.e., cannot hearwell enough to cooperate with interview).

Study Design

Total Participants: 37
Treatment Group(s): 2
Primary Treatment: iTBS repetitive Transcranial Magnetic Stimulation (rTMS)
Phase:
Study Start date:
October 05, 2016
Estimated Completion Date:
December 30, 2020

Study Description

rTMS is a treatment that involves stimulating a certain area of the brain with magnetic field pulses. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of bipolar depression. The device used in this study has been approved by Health Canada for therapeutic use since 2002. Participants will complete a screen visit to determine eligibility based on the inclusion/exclusion criteria. If the participants are not eligible, no further study procedures will be conducted. Eligible subjects will be randomized to receive either active iTBS-rTMS or sham rTMS treatment (scalp stimulation with no magnetic pulse) daily for four weeks (20 sessions) to the left dorsolateral prefrontal cortex (DLPFC). All participants will complete a MRI (to target the left DLPFC region of the brain and functional activity), EEG & fNIRS, lab work, and neurocognitive testing prior to the commencement and post rTMS treatment. Efficacy, safety and tolerability will be evaluated at screen visit, during daily rTMS treatments, clinic visits and post rTMS treatment. All participants will have a phone interview two weeks post rTMS treatment.

Connect with a study center

  • Dr. Alexander McGirr

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • Djavad Mowfaghian Centre for Brain Heath

    Vancouver, British Columbia V6T 1Z3
    Canada

    Site Not Available

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