Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder with RTMS

Not Applicable

Recruiting

• Conditions: Borderline Personality Disorder; Depressive Disorder, Major
• Interventions: Device: Left Dorsolateral Prefrontal Cortex (L-DLPFC); Device: Dorsomedial Prefrontal Cortex (DMPFC); Device: Sham Stimulation

• Registration Number: NCT04870255
• Lead Sponsor: Stanford University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-05-03
• Study Start: 2021-07-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.

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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
• Recent (during the current depressive episode) or concurrent use of a rapid acting antidepressant agent (i.e., ketamine or a course of ECT).
• History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, unexpected seizure/epilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma.
• Untreated or insufficiently treated endocrine disorder.
• Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)
• Contraindications to MRI (ferromagnetic metal in their body).
• 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.
• Depth-adjusted aiTBS treatment dose > 65% maximum stimulator output (MSO)
• Treatment with another investigational drug or other intervention within the study period.
• Any other condition deemed by the PI to interfere with the study or increase risk to the participant.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left Dorsolateral Prefrontal Cortex (L-DLPFC)	Left Dorsolateral Prefrontal Cortex (L-DLPFC)	The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)
Dorsomedial Prefrontal Cortex (DMPFC)	Dorsomedial Prefrontal Cortex (DMPFC)	The accelerated theta burst stimulation protocol will be applied to the dorsomedial prefrontal cortex (DMPFC)
Sham stimulation	Sham Stimulation	Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC) region

Primary Outcome Measures

Name	Time	Method
Change in the clinician rated Montgomery-Asberg Depression Rating Scale (MADRS-C) in active L-DLPFC vs. sham aiTBS.	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 Outcome Measures

Name	Time	Method
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.	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.
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.	Retention rates will be determined as research follow-up rate ≥80%
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.	Recruitment rate will be determined by actual recruitment/recruitment milestones
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.	Rate of suicidal behaviors will be determined by number of participants that committed a SB/total number of participants

Trial Locations

Locations (1)

Stanford Hospital; 🇺🇸 Stanford, California, United States