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

Launched by STANFORD UNIVERSITY · May 6, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called accelerated intermittent theta-burst stimulation (aiTBS) for people with bipolar II disorder who are experiencing severe depression that hasn't improved with other treatments. The study aims to see if this method can help alleviate depressive symptoms by using a special device that sends magnetic pulses to a specific area of the brain. It's important to note that participants will not know whether they are receiving the real treatment or a placebo (a treatment without active medicine) to ensure unbiased results.

To participate, individuals must be between 18 and 80 years old, diagnosed with bipolar II disorder, and currently in a major depressive episode. They should also be in good health and have been on a stable mood stabilizer for at least six weeks before joining. Participants will be closely monitored throughout the study and will have to follow certain guidelines, such as avoiding alcohol before treatment sessions and using effective birth control if they can become pregnant. If you or someone you know is struggling with treatment-resistant depression and is interested in this study, it could be a chance to explore a potential new option for relief.

Gender

ALL

Eligibility criteria

• 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.
• • 12. Agreement to adhere to Lifestyle Considerations throughout study duration.
• Lifestyle considerations:
• • 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.
• • Participants who use tobacco products will be informed that use will be allowed only in between intervention sessions.
• 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)
• • 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