RECRUITING

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

Conditions

Bipolar II Disorder, Most Recent Episode Major Depressive Current Depressive Episode Treatment Resistant Depression Bipolar II Disorder Transcranial Magnetic Stimulation (TMS)Theta Burst

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-12-20

Study Completion:2026-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05849402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 12. Agreement to adhere to Lifestyle Considerations throughout study duration. 1. Abstain from becoming pregnant from the screening visit (Visit 1) until after the final study visit (Visit 9). 2. 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. 3. Abstain from alcohol for at least 24 hours before the start of each MRI and TMS session.	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) 11. Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation) 12. Current hypomania or psychosis 13. Showing symptoms of withdrawal from alcohol or benzodiazepines 14. A diagnosis of intellectual disability 15. Parkinsonism or other movement disorder determined by Principal Investigator to interfere with treatment 16. Any other indication the Principal Investigator feels would comprise data. 17. Current active suicidal ideation or suicide attempt or suicidal behaviors in the last 6 months 18. Any history of psycho surgery for depression 19. Any history of ECT (greater than 8 sessions) without meeting responder criteria 20. Recent (within 4 weeks of any clinical effect) or concurrent use of rapid acting antidepressant agent (i.e., ketamine or a course of ECT) 22. Any history of myocardial infarction, CABG, CHF, or other cardiac history 23. The presence or diagnosis of prominent anxiety disorder, personality disorder or dysthymia 24. History of intractable migraine 25. Hypomania in the past 6 months. 26. Depth-adjusted aiTBS treatment dose \> 65% maximum stimulator output (MSO) 27. Unstable symptoms between screening and baseline as defined by a 30% change in MADRS-C score. 28. Any other condition deemed by the PI to interfere with the study or increase risk to the participant

Inclusion Criteria

Exclusion 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.
12. Agreement to adhere to Lifestyle Considerations throughout study duration.
1. Abstain from becoming pregnant from the screening visit (Visit 1) until after the final study visit (Visit 9).
2. 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.
3. Abstain from alcohol for at least 24 hours before the start of each MRI and TMS session.

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)
11. Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation)
12. Current hypomania or psychosis
13. Showing symptoms of withdrawal from alcohol or benzodiazepines
14. A diagnosis of intellectual disability
15. Parkinsonism or other movement disorder determined by Principal Investigator to interfere with treatment
16. Any other indication the Principal Investigator feels would comprise data.
17. Current active suicidal ideation or suicide attempt or suicidal behaviors in the last 6 months
18. Any history of psycho surgery for depression
19. Any history of ECT (greater than 8 sessions) without meeting responder criteria
20. Recent (within 4 weeks of any clinical effect) or concurrent use of rapid acting antidepressant agent (i.e., ketamine or a course of ECT)
22. Any history of myocardial infarction, CABG, CHF, or other cardiac history
23. The presence or diagnosis of prominent anxiety disorder, personality disorder or dysthymia
24. History of intractable migraine
25. Hypomania in the past 6 months.
26. Depth-adjusted aiTBS treatment dose \> 65% maximum stimulator output (MSO)
27. Unstable symptoms between screening and baseline as defined by a 30% change in MADRS-C score.
28. Any other condition deemed by the PI to interfere with the study or increase risk to the participant

Contacts and Locations

Study Contact

Nick Bassano, MSW

CONTACT

650-800-6929

nbassano@stanford.edu

Principal Investigator

Nolan Williams, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Bora Kim, MD

STUDY_DIRECTOR

Stanford University

Study Locations (Sites)

Stanford University

Palo Alto, California, 94305

United States

Collaborators and Investigators

Sponsor: Stanford University

Nolan Williams, MD, PRINCIPAL_INVESTIGATOR, Stanford University
Bora Kim, MD, STUDY_DIRECTOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-20

Study Completion Date2026-07-30

Study Record Updates

Study Start Date2022-12-20

Study Completion Date2026-07-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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