Accelerated Intermittent Theta-Burst Stimulation (aiTBS) in Treatment-Resistant Depression of Bipolar II Disorder
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Bipolar II Disorder, Most Recent Episode Major Depressive
- Sponsor
- Stanford University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
The aim of this study is to assess the efficacy of aiTBS applied to the left dorsolateral prefrontal cortex (L-DLPFC) in reducing depressive symptoms in individuals with bipolar II disorder, and to determine the neural functional connectivity changes that underlie treatment response. A total of 60 individuals with bipolar II disorder who are currently experiencing a depressive episode will be recruited for the study. The accelerated iTBS (aiTBS) treatment will consist of 10 sessions, administered daily over a period of 5 consecutive days. Before and after the stimulation, magnetic resonance imaging (MRI) scans, electroencephalograms (EEG), and heart rate variability (HRV) will be collected. The severity of depressive symptoms will be evaluated using both clinician-rated and self-report assessments.
Investigators
Bora Kim
Principal Investigator: Nolan Williams, MD, Stanford University / Protocol Director: Bora Kim, MD, Stanford University
Stanford University
Eligibility Criteria
Inclusion Criteria
- •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).
- •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.
- •Meet the criteria by Maudsley Staging Method score \>=7
- •Not in a current state of hypomania (as assessed by the Young Mania Rating Scale) or psychosis
- •In good general health, as ascertained by medical history.
- •Must have a stable psychiatrist during study enrollment, who confirms diagnosis of bipolar II disorder.
- •Must be on a mood stabilizer regimen for 6 weeks prior to study enrollment and agree to continue this regimen during study period
- •Meet the threshold on the MADRS, with a total score of \>/=20 at screening/baseline.
- •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.
- •Agreement to adhere to Lifestyle Considerations throughout study duration.
Exclusion Criteria
- •Primary diagnosis other than bipolar II disorder
- •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.
- •Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear implants
- •History of epilepsy or seizures
- •Shrapnel or any ferromagnetic item in the head
- •Autism Spectrum disorder
- •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
- •Active substance abuse (\<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
- •Cognitive impairment (including dementia)
- •Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation)
Outcomes
Primary Outcomes
Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: Baseline and immediately post-treatment, 1-month
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS uses a 0 to 6 severity scale, scored following the interview. Scoring/Interpretation: Higher scores indicate increasing depressive symptoms. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Secondary Outcomes
- Change in resting-state functional connectivity(After all stimulation sessions have been completed (approximately 48 hours after the final session))
- Change from baseline Young Mania Rating Scale (YMRS)(Baseline and immediate post-treatment, 1-month)