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

July 17, 2023 updated by: David Spiegel, Stanford University

Modulating Probabilities: Prediction, Assessment, and Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford hospital
        • Principal Investigator:
          • Nolan Williams, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or Female, between the ages of 22 and 65 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham stimulation
Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC) region
Device: Sham Stimulation

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.
Active Comparator: Left Dorsolateral Prefrontal Cortex (L-DLPFC)
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (L-DLPFC)
Device: Left Dorsolateral Prefrontal Cortex (L-DLPFC)

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.
Active Comparator: Dorsomedial Prefrontal Cortex (DMPFC)
The accelerated theta burst stimulation protocol will be applied to the dorsomedial prefrontal cortex (DMPFC)
Device: Dorsomedial Prefrontal Cortex (DMPFC)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline (pre-intervention), during the intervention and immediately after the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the clinician rated Montgomery-Asberg Depression Rating Scale (MADRS-C) in active DMPFC 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.
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
Time Frame: At baseline (pre-intervention), during the intervention and immediately after the intervention.
Retention rates will be determined as research follow-up rate ≥80%
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
Time Frame: At baseline (pre-intervention), during the intervention and immediately after the intervention.
Recruitment rate will be determined by actual recruitment/recruitment milestones
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
Time Frame: 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
At baseline (pre-intervention), during the intervention and immediately after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Study Director: Nolan Williams, MD, Stanford University
  • Principal Investigator: David Spiegel, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58950

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depressive Disorder, Major

Clinical Trials on Sham Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe