Dorsomedial Prefrontal Cortex (DMPFC) for Psychosis, Involutional

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Psychosis, Involutional+4 More
Left Dorsolateral Prefrontal Cortex (L-DLPFC) - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at whether a new kind of brain stimulation called "aiTBS" can help people with borderline personality disorder who also have depression.

Eligible Conditions
  • Psychosis, Involutional
  • Borderline Personality Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Psychosis, Involutional

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: At baseline (day 2) and at post-inpatient treatment completion (day 3-7)

Day 2
Change in Borderline Symptoms List-23 (BSL-23) in active vs. sham participants.
Day 3
Mental Depression
Change in the clinician rated Montgomery-Asberg Depression Rating Scale (MADRS-C) in active vs. sham participants.
Day 3
Change in the clinician rated Montgomery-Asberg Depression Rating Scale (MADRS-C) in active DMPFC vs. sham aiTBS.
At baseline and post-inpatient treatment completion (day3-7)
Safety of aiTBS in hospitalized patients with BPD and comorbid MDD or BAD II in a current MDE as defined by rate of suicidal behaviors
Between start and end of recruitment
Borderline Personality Disorder
Feasibility of aiTBS in hospitalized patients with BPD and comorbid MDD or BAD II in a current MDE as defined by retention rates

Trial Safety

Safety Progress

1 of 3

Other trials for Psychosis, Involutional

Trial Design

3 Treatment Groups

Dorsomedial Prefrontal Cortex (DMPFC)
1 of 3
Left Dorsolateral Prefrontal Cortex (L-DLPFC)
1 of 3
Sham stimulation
1 of 3
Active Control
Non-Treatment Group

45 Total Participants · 3 Treatment Groups

Primary Treatment: Dorsomedial Prefrontal Cortex (DMPFC) · Has Placebo Group · N/A

Sham stimulation
Device
ShamComparator Group · 1 Intervention: Sham Stimulation · Intervention Types: Device
Dorsomedial Prefrontal Cortex (DMPFC)
Device
ActiveComparator Group · 1 Intervention: Dorsomedial Prefrontal Cortex (DMPFC) · Intervention Types: Device
Left Dorsolateral Prefrontal Cortex (L-DLPFC)
Device
ActiveComparator Group · 1 Intervention: Left Dorsolateral Prefrontal Cortex (L-DLPFC) · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at baseline (day 2) and at post-inpatient treatment completion (day 3-7)

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,148 Previous Clinical Trials
35,678,959 Total Patients Enrolled
Nolan Williams, MDStudy DirectorStanford University
15 Previous Clinical Trials
893 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Before taking part in the study, all females of reproductive potential must use a highly effective form of contraception for at least one month, and agree to continue using contraception during the study.
The individual has been diagnosed with Major Depressive Disorder, Bipolar Affective Disorder II, or unspecified depressive disorder, as well as Borderline Personality Disorder, and is currently experiencing a Mood Depressive Episode.
There is a possibility that you will be able to continue to have access to clinical rTMS after your study participation is completed
I agree to follow the lifestyle recommendations listed in section 5.3 for the duration of the study.
HAMD-17 and MADRS score of ≥20 at screening (Visit 1) is an indication for treatment with antidepressant medication.
TMS is unaware.
You must be a man or woman, between the ages of 22 and 65 to be screened.
The individual is generally in good health, as evidenced by their medical history.
Participants in the study will have access to psychiatric care before and after the study is completed.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: October 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References