Intensive TMS for Bipolar Depression

Last updated: February 21, 2025
Sponsor: University of Pennsylvania
Overall Status: Completed

Phase

N/A

Condition

Bipolar Disorder

Mood Disorders

Depression (Major/severe)

Treatment

Intensive intermittent theta-burst stimulation (iTBS)

Clinical Study ID

NCT05228457
850359
  • Ages 18-70
  • All Genders

Study Summary

The research study is being conducted to test whether using high dose spaced theta-burst rTMS (a form of transcranial magnetic stimulation) produces a significant reduction in depressive symptoms compared with sham. This project will recruit patients aged 18-70 with symptoms of bipolar depression who have failed (or not shown signs of improvement) after at least two prior treatments.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Bipolar depression (BP I and BP II) by Diagnostic and Statistical Manual 5 (DSM 5)criteria

  • Age 18-70

  • Right or left handed

  • All genders

  • Treatment resistant depression, as in they must have treatment resistant depressionwith 2 or more prior antidepressant trials that have failed to produce a response (> 50% reduction in symptoms) using ATHF criteria

  • Able to provide informed consent to participate in the study

  • Must be on a stable medication regimen, requiring at least one mood stabilizer

  • Depression severity as represented by scoring at least 20 on Montgomery-AsbergDepression Rating Scale (MADRS)

Exclusion

Exclusion Criteria:

  • No current substance abuse disorder for the past 6 months (previous substance abusenot exclusionary)

  • Any psychotic disorder or current active psychotic symptoms (personality disordersnot exclusionary unless in the opinion of the referring psychiatrist it wouldjeopardize participation)

  • No dementia or other major neurological disorders

  • Not having depression as primary disorder

  • No major medical illness, for example metastatic cancer, end stage renal disease

  • Not able to verify contact information. Participants must be able to follow throughwith the study & must have verified contact information and at least one verifiedcontact

  • Pregnancy. While there are no known risks to a fetus this is a new use of TMS, whichhas not been tested, thus pregnancy is exclusionary

  • Score on Young Mania Rating Scale (YMRS) greater than 12 (patients with mixedfeatures have been shown not to respond well to TMS treatment)

  • Rapid cycling Bipolar illness (patients with > 4 mood episodes within the past yearwill be excluded, as they have a higher risk of switch to mania)

  • Any implants, conditions, or contraindications that would be deemed unsafe for TMSor MRI

  • Currently using benzodiazepines (such as lorazepam) with a dose >1 mg per day orequivalent.

Study Design

Total Participants: 34
Treatment Group(s): 1
Primary Treatment: Intensive intermittent theta-burst stimulation (iTBS)
Phase:
Study Start date:
March 01, 2022
Estimated Completion Date:
February 19, 2024

Study Description

The research study is being conducted to test whether using high dose spaced theta-burst rTMS (a form of transcranial magnetic stimulation) produces a significant reduction in depressive symptoms compared with sham. This project will recruit patients aged 18-70 with symptoms of bipolar depression who have failed (or not shown signs of improvement) after at least two prior treatments. The null hypothesis is that there will be no difference in reductions in depressive symptoms by the end of a five-day treatment period. The alternative hypothesis is that, compared with sham, active TMS will result in a greater reduction in depressive symptoms by the end of the treatment period. Participants will be randomly assigned to active or sham conditions: 50% to active and 50% to sham.

Connect with a study center

  • Center for Neuromodulation in Depression and Stress, University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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