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

NCT05849402 | Recruiting FDA Device

• 1 other identifier: 49486-RCT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar II Disorder, Most Recent Episode Major Depressive; Current Depressive Episode; Treatment Resistant Depression

Keywords

Bipolar II Disorder; Treatment Resistant Depression; Transcranial Magnetic Stimulation (TMS); Theta Burst

Outcome Measures

Primary Outcomes (1)

• Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)

  A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS uses a 0 to 6 severity scale, scored following the interview. Scoring/Interpretation: Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.

  Baseline and immediately post-treatment, 1-month

Secondary Outcomes (2)

• Change from baseline Young Mania Rating Scale (YMRS)

  Baseline and immediate post-treatment, 1-month

• Change in resting-state functional connectivity

  After all stimulation sessions have been completed (approximately 48 hours after the final session)

Study Arms (2)

Active aiTBS

ACTIVE COMPARATOR

Participants will be randomized to active or sham aiTBS condition, and receive 10 aiTBS to left DLPFC (LDLPFC) sessions a day for 5 days of course.

Device: Active Comparator: Active aiTBS

Sham aiTBS

SHAM COMPARATOR

Participants will be randomized to active or sham aiTBS condition, and receive 10 aiTBS to left DLPFC (LDLPFC) sessions a day for 5 days of course.

Device: Sham Comparator: Sham aiTBS

Interventions

Active Comparator: Active aiTBS DEVICE

Participants will be randomized to active or sham aiTBS condition, and receive 10 aiTBS to left DLPFC (LDLPFC) sessions a day for 5 days of course.

Active aiTBS

Sham Comparator: Sham aiTBS DEVICE

Participants will be randomized to active or sham aiTBS condition, and receive 10 aiTBS to left DLPFC (LDLPFC) sessions a day for 5 days of course.

Sham aiTBS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• Meet the criteria by Maudsley Staging Method score \>=7
• Not in a current state of hypomania (as assessed by the Young Mania Rating Scale) or psychosis
• In good general health, as ascertained by medical history.
• Must have a stable psychiatrist during study enrollment, who confirms diagnosis of bipolar II disorder.
• Must be on a mood stabilizer regimen for 6 weeks prior to study enrollment and agree to continue this regimen during study period
• Meet the threshold on the MADRS, with a total score of \>/=20 at screening/baseline.
• TMS Naive
• \. 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.
• \. Agreement to adhere to Lifestyle Considerations throughout study duration.
• Lifestyle considerations:
• Abstain from becoming pregnant from the screening visit (Visit 1) until after the final study visit (Visit 9).
• Continue usual intake patterns of caffeine- or xanthine-containing products (e.g., coffee, tea, cola drinks, and chocolate) without significant change for the duration of the study.
• Abstain from alcohol for at least 24 hours before the start of each MRI and TMS session.

You may not qualify if:

• Primary diagnosis other than bipolar II disorder
• 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.
• Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear implants
• History of epilepsy or seizures
• Shrapnel or any ferromagnetic item in the head
• Pregnancy
• Autism Spectrum disorder
• 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
• Active substance abuse (\<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
• Cognitive impairment (including dementia)
• Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation)
• Current hypomania or psychosis
• Showing symptoms of withdrawal from alcohol or benzodiazepines
• A diagnosis of intellectual disability
• Parkinsonism or other movement disorder determined by Principal Investigator to interfere with treatment

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

RECRUITING

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MeSH Terms

Conditions

Bipolar Disorder; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Depressive Disorder

Study Officials

• Nolan Williams, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Bora Kim, MD

  Stanford University

  STUDY DIRECTOR

Central Study Contacts

Nick Bassano, MSW

CONTACT

650-800-6929; nbassano@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator: Nolan Williams, MD, Stanford University / Protocol Director: Bora Kim, MD, Stanford University

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 8, 2023
• Study Start: December 20, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)