Dorsomedial Prefrontal Cortex (DMPFC) for Psychosis, Involutional
Phase-Based Progress Estimates
Effectiveness
Safety
Psychosis, Involutional+4 More
Left Dorsolateral Prefrontal Cortex (L-DLPFC) - DeviceEligibility
18+
All Sexes
What conditions do you have?
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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
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
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: DeviceDorsomedial Prefrontal Cortex (DMPFC)
Device
ActiveComparator Group · 1 Intervention: Dorsomedial Prefrontal Cortex (DMPFC) · Intervention Types: DeviceLeft Dorsolateral Prefrontal Cortex (L-DLPFC)
Device
ActiveComparator Group · 1 Intervention: Left Dorsolateral Prefrontal Cortex (L-DLPFC) · Intervention Types: DeviceTrial 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 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
- Pascual-Leone, Alvaro, Belen Rubio, Federico Pallardó, and Maria Dolores Catalá. 1996. “Rapid-rate Transcranial Magnetic Stimulation of Left Dorsolateral Prefrontal Cortex in Drug-resistant Depression”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(96)01219-6.
- Tello, Nina, Ghina Harika-Germaneau, Wilfried Serra, Nematollah Jaafari, and Armand Chatard. 2019. “Forecasting a Fatal Decision: Direct Replication of the Predictive Validity of the Suicide–implicit Association Test”. Psychological Science. SAGE Publications. doi:10.1177/0956797619893062.
- Schmaal, Lianne, Anne-Laura van Harmelen, Vasiliki Chatzi, Elizabeth T. C. Lippard, Yara J. Toenders, Lynnette A. Averill, Carolyn M. Mazure, and Hilary P. Blumberg. 2019. “Imaging Suicidal Thoughts and Behaviors: A Comprehensive Review of 2 Decades of Neuroimaging Studies”. Molecular Psychiatry. Springer Science and Business Media LLC. doi:10.1038/s41380-019-0587-x.
- Liston, Conor, Ashley C. Chen, Benjamin D. Zebley, Andrew T. Drysdale, Rebecca Gordon, Bruce Leuchter, Henning U. Voss, B.J. Casey, Amit Etkin, and Marc J. Dubin. 2014. “Default Mode Network Mechanisms of Transcranial Magnetic Stimulation in Depression”. Biological Psychiatry. Elsevier BV. doi:10.1016/j.biopsych.2014.01.023.
- George, Mark S., Eric M. Wassermann, Wendol A. Williams, Ann Callahan, Terence A. Ketter, Peter Basser, Mark Hallett, and Robert M. Post. 1995. “Daily Repetitive Transcranial Magnetic Stimulation (rtms) Improves Mood in Depression”. Neuroreport. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00001756-199510020-00008.
- Ballard, Elizabeth D., Jessica L. Reed, Joanna Szczepanik, Jennifer W. Evans, Julia S. Yarrington, Daniel P. Dickstein, Matthew K. Nock, Allison C. Nugent, and Carlos A. Zarate Jr.. 2019. “Functional Imaging of the Implicit Association of the Self with Life and Death”. Suicide and Life-threatening Behavior. Wiley. doi:10.1111/sltb.12543.
- Duprat, Romain, Rudi De Raedt, Guo-Rong Wu, and Chris Baeken. 2016. “Intermittent Theta Burst Stimulation Increases Reward Responsiveness in Individuals with Higher Hedonic Capacity”. Frontiers in Human Neuroscience. Frontiers Media SA. doi:10.3389/fnhum.2016.00294.
- George, Mark S., Sarah H. Lisanby, David Avery, William M. McDonald, Valerie Durkalski, Martina Pavlicova, Berry Anderson, et al.. 2010. “Daily Left Prefrontal Transcranial Magnetic Stimulation Therapy for Major Depressive Disorder”. Archives of General Psychiatry. American Medical Association (AMA). doi:10.1001/archgenpsychiatry.2010.46.
- Green, Kelly L., Gregory K. Brown, Shari Jager-Hyman, Jason Cha, Robert A. Steer, and Aaron T. Beck. 2015. “The Predictive Validity of the Beck Depression Inventory Suicide Item”. The Journal of Clinical Psychiatry. Physicians Postgraduate Press, Inc. doi:10.4088/jcp.14m09391.
- Baeken, Chris, Romain Duprat, Guo-Rong Wu, Rudi De Raedt, and Kees van Heeringen. 2017. “Subgenual Anterior Cingulate–medial Orbitofrontal Functional Connectivity in Medication-resistant Major Depression: A Neurobiological Marker for Accelerated Intermittent Theta Burst Stimulation Treatment?”. Biological Psychiatry: Cognitive Neuroscience and Neuroimaging. Elsevier BV. doi:10.1016/j.bpsc.2017.01.001.
- Downar, Jonathan, Joseph Geraci, Tim V. Salomons, Katharine Dunlop, Sarah Wheeler, Mary Pat McAndrews, Nathan Bakker, et al.. 2014. “Anhedonia and Reward-circuit Connectivity Distinguish Nonresponders from Responders to Dorsomedial Prefrontal Repetitive Transcranial Magnetic Stimulation in Major Depression”. Biological Psychiatry. Elsevier BV. doi:10.1016/j.biopsych.2013.10.026.
- Light, Sharee N., Linas A. Bieliauskas, and Stephan F. Taylor. 2019. “Measuring Change in Anhedonia Using the “happy Faces” Task Pre- to Post-repetitive Transcranial Magnetic Stimulation (rtms) Treatment to Left Dorsolateral Prefrontal Cortex in Major Depressive Disorder (MDD): Relation to Empathic Happiness”. Translational Psychiatry. Springer Science and Business Media LLC. doi:10.1038/s41398-019-0549-8.
- Abdallah, Chadi G, Lynnette A Averill, Katherine A Collins, Paul Geha, Jaclyn Schwartz, Christopher Averill, Kaitlin E DeWilde, et al.. 2016. “Ketamine Treatment and Global Brain Connectivity in Major Depression”. Neuropsychopharmacology. Springer Science and Business Media LLC. doi:10.1038/npp.2016.186.
- Gärtner, Matti, Sabine Aust, Malek Bajbouj, Yan Fan, Katja Wingenfeld, Christian Otte, Isabella Heuser-Collier, et al.. 2019. “Functional Connectivity Between Prefrontal Cortex and Subgenual Cingulate Predicts Antidepressant Effects of Ketamine”. European Neuropsychopharmacology. Elsevier BV. doi:10.1016/j.euroneuro.2019.02.008.
- Ballard, Elizabeth D., Jessica L. Reed, Joanna Szczepanik, Jennifer W. Evans, Julia S. Yarrington, Daniel P. Dickstein, Matthew K. Nock, Allison C. Nugent, and Carlos A. Zarate Jr.. 2019. “Functional Imaging of the Implicit Association of the Self with Life and Death”. Suicide and Life-threatening Behavior. Wiley. doi:10.1111/sltb.12543.
- Gärtner, Matti, Sabine Aust, Malek Bajbouj, Yan Fan, Katja Wingenfeld, Christian Otte, Isabella Heuser-Collier, et al.. 2019. “Functional Connectivity Between Prefrontal Cortex and Subgenual Cingulate Predicts Antidepressant Effects of Ketamine”. European Neuropsychopharmacology. Elsevier BV. doi:10.1016/j.euroneuro.2019.02.008.
- Jean-Marie Batail 2021. "Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04870255.
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