Actively Recruiting
Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder
Led by Stanford University · Updated on 2024-04-30
60
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years with bipolar II disorder in a current major depressive episode per DSM-V criteria
- Able to read, understand, and provide written informed consent
- Maudsley Staging Method score of 7 or higher
- Not currently experiencing hypomania or psychosis
- In good general health based on medical history
- Have a stable psychiatrist confirming bipolar II diagnosis
- On a stable mood stabilizer regimen for at least 6 weeks and agree to continue during the study
- Montgomery Asberg Depression Rating Scale (MADRS) score of 20 or higher at screening or baseline
- No prior transcranial magnetic stimulation (TMS) treatment
- For females of reproductive potential, use highly effective contraception for at least 1 month before screening and during study participation
- Agree to lifestyle considerations such as avoiding pregnancy during the study and maintaining usual caffeine intake
- Abstain from alcohol for at least 24 hours before each MRI and TMS session
You will not qualify if you...
- Primary diagnosis other than bipolar II disorder
- Structural neurological conditions or brain lesions affecting safety or study interpretation
- Presence of metal brain implants, cardiac pacemakers, or cochlear implants
- History of epilepsy or seizures
- Presence of ferromagnetic items such as shrapnel in the head
- Pregnancy
- Autism Spectrum Disorder
- Any physical condition that may increase risk or interfere with study results
- Active substance abuse or intoxication within one week
- Cognitive impairment including dementia
- Severe insomnia preventing at least 5 hours of sleep before stimulation
- Current hypomania or psychosis
- Symptoms of withdrawal from alcohol or benzodiazepines
- Intellectual disability
- Parkinsonism or movement disorders interfering with treatment
- Any condition deemed by the Principal Investigator to compromise data
- Current active suicidal ideation or recent suicidal behaviors in the past 6 months
- History of psychosurgery for depression
- History of electroconvulsive therapy (ECT) exceeding 8 sessions without response
- Recent or concurrent use of rapid-acting antidepressants like ketamine or ECT within 4 weeks
- History of serious cardiac conditions such as myocardial infarction or heart failure
- Prominent anxiety disorder, personality disorder, or dysthymia
- History of intractable migraine
- Hypomania within the past 6 months
- aiTBS treatment dose exceeding 65% maximum stimulator output
- Unstable symptoms between screening and baseline defined by 30% change in MADRS score
- Any other condition considered unsafe or interfering by the Principal Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94305
Actively Recruiting
Research Team
N
Nick Bassano, MSW
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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