RECRUITING

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

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Conditions

Depressive Disorder, MajorBorderline Personality DisorderDepressionNeuromodulationTranscranial Magnetic Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2021-07-20
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04870255

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.

Ages Eligible for Study:22 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or Female, between the ages of 22 and 65 at the time of screening.
  2. * 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.
  3. * 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).
  4. * MADRS score of ≥20 at screening (Visit 1).
  5. * TMS naive.
  6. * Access to ongoing psychiatric care before and after completion of the study.
  7. * Access to clinical rTMS after study completion.
  8. * In good general health, as evidenced by medical history.
  9. * 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.
  10. * Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration.
  1. * Pregnancy
  2. * The presence or diagnosis of prominent anxiety disorder, personality disorder, or dysthymia
  3. * Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation)
  4. * Current mania or psychosis
  5. * Bipolar I Disorder and primary psychotic disorders.
  6. * Autism Spectrum disorder or Intellectual Disability
  7. * A diagnosis of obsessive-compulsive disorder (OCD)
  8. * Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal.
  9. * Urine screening test positive for illicit substances.
  10. * Any history of ECT (greater than 8 sessions) without meeting responder criteria
  11. * Recent (during the current depressive episode) or concurrent use of a rapid acting antidepressant agent (i.e., ketamine or a course of ECT).
  12. * 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.
  13. * Untreated or insufficiently treated endocrine disorder.
  14. * Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion)
  15. * Contraindications to MRI (ferromagnetic metal in their body).
  16. * 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.
  17. * Depth-adjusted aiTBS treatment dose \> 65% maximum stimulator output (MSO)
  18. * Treatment with another investigational drug or other intervention within the study period.
  19. * Any other condition deemed by the PI to interfere with the study or increase risk to the participant.

Contacts and Locations

Study Contact

Bora Kim, MD, MAS
CONTACT
650-800-6929
borakim2@stanford.edu
Nick Bassano, MSW
CONTACT
650-800-6929
nbassano@stanford.edu

Principal Investigator

Nolan Williams, MD
STUDY_DIRECTOR
Stanford University
David Spiegel, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford Hospital
Stanford, California, 94305
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Nolan Williams, MD, STUDY_DIRECTOR, Stanford University
  • David Spiegel, MD, PRINCIPAL_INVESTIGATOR, Stanford University

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 Registration Dates

Study Start Date2021-07-20
Study Completion Date2025-06

Study Record Updates

Study Start Date2021-07-20
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • Depression
  • Neuromodulation
  • Transcranial Magnetic Stimulation
  • Borderline Personality Disorder

Additional Relevant MeSH Terms

  • Depressive Disorder, Major
  • Borderline Personality Disorder