Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS

NCT04870255 | Active Not Recruiting FDA Device

• 1 other identifier: 58950
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Depressive Disorder, Major; Borderline Personality Disorder

Keywords

Depression; Neuromodulation; Transcranial Magnetic Stimulation; Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

• Change in the clinician rated Montgomery-Asberg Depression Rating Scale (MADRS-C) in active L-DLPFC vs. sham aiTBS.

  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.

  At baseline (pre-intervention), during the intervention and immediately after the intervention.

Secondary Outcomes (4)

• 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.

Study Arms (3)

Left Dorsolateral Prefrontal Cortex (L-DLPFC)

ACTIVE COMPARATOR

The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)

Device: Left Dorsolateral Prefrontal Cortex (L-DLPFC)

Dorsomedial Prefrontal Cortex (DMPFC)

ACTIVE COMPARATOR

The accelerated theta burst stimulation protocol will be applied to the dorsomedial prefrontal cortex (DMPFC)

Device: Dorsomedial Prefrontal Cortex (DMPFC)

Sham stimulation

SHAM COMPARATOR

Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC) region

Device: Sham Stimulation

Interventions

Left Dorsolateral Prefrontal Cortex (L-DLPFC) DEVICE

Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the left DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Magventure Magpro X100 TMS system.

Left Dorsolateral Prefrontal Cortex (L-DLPFC)

Dorsomedial Prefrontal Cortex (DMPFC) DEVICE

Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the DMPFC. Stimulation intensity will be standardized at 100% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Magventure Magpro X100 TMS system.

Dorsomedial Prefrontal Cortex (DMPFC)

Sham Stimulation DEVICE

Participants who are randomly assigned to this group will receive sham stimulation to the left DLPFC. Sham stimulation will be delivered using the Magventure Magpro X100 TMS system.

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital

Stanford, California, 94305, United States

Location

Related Publications (14)

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MeSH Terms

Conditions

Depressive Disorder, Major; Borderline Personality Disorder; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Personality Disorders; Behavioral Symptoms; Behavior

Study Officials

• Nolan Williams, MD

  Stanford University

  STUDY DIRECTOR

• David Spiegel, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psych/Major Laboratories and Clinical & Translational Neuroscience

Model Details: Patients will be randomized to receive: active L-DLPFC stimulation, active DMPFC stimulation, or sham stimulation. Group size ratio will be 1:1:1.

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: July 20, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)