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Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder | Clinical Trials | Clareo Health

RECRUITINGNA

Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder

NCT05849402•Stanford University

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the effectiveness of accelerated intermittent theta-burst transcranial magnetic stimulation (aiTBS) in inducing anti-depressant responses in individuals with treatment-resistant depression of bipolar II disorder. This is a double-blind, randomized, sham-controlled trial that targets a single location on the left dorsolateral prefrontal cortex (LDLPFC) using the MagPro rTMS system.

Detailed Description

The aim of this study is to assess the efficacy of aiTBS applied to the left dorsolateral prefrontal cortex (L-DLPFC) in reducing depressive symptoms in individuals with bipolar II disorder, and to determine the neural functional connectivity changes that underlie treatment response. A total of 60 individuals with bipolar II disorder who are currently experiencing a depressive episode will be recruited for the study. The accelerated iTBS (aiTBS) treatment will consist of 10 sessions, administered daily over a period of 5 consecutive days. Before and after the stimulation, magnetic resonance imaging (MRI) scans, electroencephalograms (EEG), and heart rate variability (HRV) will be collected. The severity of depressive symptoms will be evaluated using both clinician-rated and self-report assessments.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants aged 18 years old to 80 years old with a primary diagnosis of bipolar affective disorder II in a current major depressive episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Fourth Edition, Text Revision (DSM-V).
•2. Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
•3. Meet the criteria by Maudsley Staging Method score \>=7
•4. Not in a current state of hypomania (as assessed by the Young Mania Rating Scale) or psychosis
•5. In good general health, as ascertained by medical history.
•6. Must have a stable psychiatrist during study enrollment, who confirms diagnosis of bipolar II disorder.
•7. Must be on a mood stabilizer regimen for 6 weeks prior to study enrollment and agree to continue this regimen during study period
•8. Meet the threshold on the MADRS, with a total score of \>/=20 at screening/baseline.
•9. TMS Naive
•11\. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
+6 more criteria

Exclusion Criteria

•1. Primary diagnosis other than bipolar II disorder
•2. Any structural lesion e.g. structural neurological condition, more subcortical lesions than would be expected for age, stroke effecting stimulated area or connected areas or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results.
•3. Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear implants
•4. History of epilepsy or seizures
•5. Shrapnel or any ferromagnetic item in the head
•6. Pregnancy
•7. Autism Spectrum disorder
•8. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation
•9. Active substance abuse (\<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
•10. Cognitive impairment (including dementia)
+17 more criteria

Locations (1)

Stanford University

Palo Alto, California, United States

Key Dates

Start Date

December 20, 2022

Primary Completion Date

July 1, 2026

Completion Date

July 30, 2026

Last Updated

April 30, 2024

Enrollment

ESTIMATED participants

Conditions

Bipolar II Disorder, Most Recent Episode Major DepressiveCurrent Depressive EpisodeTreatment Resistant Depression

Interventions

Active Comparator: Active aiTBS

DEVICE

Sham Comparator: Sham aiTBS

DEVICE

Contacts

Nick Bassano, MSW

CONTACT

650-800-6929 nbassano@stanford.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

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