Using accelerated theta-burst stimulation to treat depression in bipolar II disorder
Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder
This study is testing if a new type of brain stimulation can help people with bipolar II disorder who haven't found relief from their depression with other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05849402 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of accelerated intermittent theta-burst transcranial magnetic stimulation (aiTBS) in reducing depressive symptoms in individuals with treatment-resistant bipolar II disorder. It is a double-blind, randomized, sham-controlled trial targeting the left dorsolateral prefrontal cortex (L-DLPFC) with a total of 60 participants. The treatment consists of 10 sessions over 5 consecutive days, with assessments including MRI scans, EEG, and heart rate variability before and after stimulation. The severity of depressive symptoms will be evaluated through clinician-rated and self-report measures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a primary diagnosis of bipolar II disorder currently experiencing a major depressive episode.
Not a fit: Patients who are currently in a state of hypomania or psychosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from treatment-resistant depression associated with bipolar II disorder.
How similar studies have performed: Other studies have shown promise with similar approaches using transcranial magnetic stimulation, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California
- Stanford University — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Nolan Williams, MD — Stanford University
- Study coordinator: Nick Bassano, MSW
- Email: nbassano@stanford.edu
- Phone: 650-800-6929
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.