Magnetic pulses aim to lift depression in bipolar II
NCT ID NCT05849402
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests whether a rapid form of brain stimulation, called accelerated intermittent theta-burst stimulation (aiTBS), can relieve depression in people with bipolar II disorder whose depression has not responded to other treatments. Participants receive either real or sham (inactive) stimulation to the left prefrontal cortex over five days. The goal is to see if aiTBS can safely reduce depressive symptoms without the need for medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- accelerated intermittent theta-burst transcranial magnetic stimulation (aiTBS)
- What this could lead to
- If effective, aiTBS could offer a non-drug option for people with bipolar II depression who haven't responded to standard treatments.
- What could go wrong
- This is a small, early-stage trial with 60 participants, and the sham comparison means some may not benefit. Brain stimulation can cause discomfort or rare side effects like seizure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Stanford University
Palo Alto, California, 94305, United States
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