Modulating Probabilities: Prediction, Assessment, and Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depressive Disorder, Major
- Sponsor
- Stanford University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Change in the clinician rated Montgomery-Asberg Depression Rating Scale (MADRS-C) in active L-DLPFC vs. sham aiTBS.
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
This study evaluates the antidepressant effects of an accelerated schedule of theta-burst stimulation, termed accelerated intermittent theta-burst stimulation (aiTBS), in individuals with borderline personality disorder (BPD) or trait and comorbid mood depressive disorder (MDD) or bipolar II disorder in a current mood depressive episode (MDE).
Detailed Description
This project aims to measure and modulate a mood depressive episode (MDE) in individuals with borderline personality disorder (BPD) trait and comorbid mood depressive disorder (MDD) or bipolar II disorder in a current mood depressive episode (MDE). This study will test the antidepressant effect of aiTBS stimulation over the left dorsolateral prefrontal cortex (L-DLPFC), and aiTBS stimulation over the dorsomedial prefrontal cortex (DMPFC) compared with sham.
Investigators
David Spiegel
Professor, Psych/Major Laboratories and Clinical & Translational Neuroscience
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Male or Female, between the ages of 18 and 80 at the time of screening.
- •Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
- •Diagnosed with Major Depressive Disorder (MDD) or Bipolar II, or unspecified depressive disorder AND Borderline Personality Disorder or trait, with a current Mood Depressive Episode (MDE), according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
- •MADRS score of ≥20 at screening (Visit 1).
- •TMS naive.
- •Access to ongoing psychiatric care before and after completion of the study.
- •Access to clinical rTMS after study completion.
- •In good general health, as evidenced by medical history.
- •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 (see section 5.3) throughout study duration.
Exclusion Criteria
- •Pregnancy
- •The presence or diagnosis of prominent anxiety disorder, personality disorder, or dysthymia
- •Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)
- •Current mania or psychosis
- •Bipolar I Disorder and primary psychotic disorders.
- •Autism Spectrum disorder or Intellectual Disability
- •A diagnosis of obsessive-compulsive disorder (OCD)
- •Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal.
- •Urine screening test positive for illicit substances.
- •Any history of ECT (greater than 8 sessions) without meeting responder criteria
Outcomes
Primary Outcomes
Change in the clinician rated Montgomery-Asberg Depression Rating Scale (MADRS-C) in active L-DLPFC vs. sham aiTBS.
Time Frame: At baseline (pre-intervention), during the intervention and immediately after the intervention.
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.The MADRS-C has an overall score range from 0-60, with higher scores corresponding to higher levels of depression.
Secondary Outcomes
- Change in the clinician rated Montgomery-Asberg Depression Rating Scale (MADRS-C) in active DMPFC vs. sham aiTBS.(At baseline (pre-intervention), during the intervention and immediately after the intervention.)
- Feasibility of aiTBS in individuals with BPD and comorbid MDD or BAD II in a current MDE as defined by retention rates(At baseline (pre-intervention), during the intervention and immediately after the intervention.)
- Feasibility of aiTBS in individuals with BPD and comorbid MDD or BAD II in a current MDE as defined by recruitment rate(At baseline (pre-intervention), during the intervention and immediately after the intervention.)
- Safety of aiTBS in individuals with BPD and comorbid MDD or BAD II in a current MDE as defined by rate of suicidal behaviors(At baseline (pre-intervention), during the intervention and immediately after the intervention.)