Study Summary
This trial will test whether psilocybin is a safe and effective treatment for major depressive disorder and borderline personality disorder.
Eligible Conditions
- Depression
- Borderline Personality Disorder
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 2 Secondary · Reporting Duration: Week 2 to Week 5
Baseline to Week 5
Clinical Global Impression - Severity scale (CGI-S)
Montgomery-Asberg Depression Rating Scale (MADRS)
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)
Week 5
Clinical Global Impression - Improvement scale (CGI-I)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Diphenhydramine
9%Nausea
7%Viral upper resp. tract infection
7%Pain
7%Bronchitis
7%Back pain
4%Suicidal Ideation
4%Diarrhea
4%Depressed mood
4%Influenza
4%Headache
4%Sinus headache
4%Alcohol withdrawal syndrome
4%Depression
4%Insomnia
4%Lower resp. tract congestion
4%Oropharyngeal pain
2%Migraine
2%Oedema
2%Bronchitis bacterial
2%Constipation
2%Pyrexia
2%Hypoesthesia
2%Influenza like Illness
2%Anger
2%Peripheral swelling
2%Mallory-Weiss Syndrom
2%Anemia
2%Thrombocytosis
2%Vomiting
2%Dermatitis contact
2%Eye infection
2%Fungal infection
2%Gingivitis
2%Traumatic lung injury
2%Hyponatremia
2%Arthralgia
2%Musculoskeletal pain
2%Pain in extremity
2%Malignant melanoma
2%Dizziness
2%Sedation
2%Anxiety
2%Restlessness
2%Cough
2%Rhinorrhea
2%Sinus congestion
2%Sexual abuse
2%Arthoscopic surgery
2%Endodontic procedure
Trial Design
1 Treatment Group
Experimental: Psilocybin
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: Psilocybin · No Placebo Group · Phase 2
Experimental: Psilocybin
Drug
Experimental Group · 1 Intervention: Psilocybin · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~560
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 2 to week 5
Who is running the clinical trial?
University of ChicagoLead Sponsor
927 Previous Clinical Trials
754,002 Total Patients Enrolled
16 Trials studying Depression
11,097 Patients Enrolled for Depression
Usona InstituteOTHER
11 Previous Clinical Trials
484 Total Patients Enrolled
6 Trials studying Depression
352 Patients Enrolled for Depression
Jon E Grant, MD, JD, MPHPrincipal InvestigatorUniversity of Chicago
8 Previous Clinical Trials
443 Total Patients Enrolled
Eligibility Criteria
Age 18 - 65 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have been diagnosed with current major depressive disorder.
You have borderline personality disorder.
Who else is applying?
What state do they live in?
| Illinois | 34.9% |
| Indiana | 6.0% |
| California | 4.8% |
| Other | 54.2% |
How old are they?
| 18 - 65 | 98.8% |
| 65+ | 1.2% |
What site did they apply to?
| University of Chicago | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 89.0% |
| Did not meet criteria | 11.0% |
Why did patients apply to this trial?
- "I like to study what medications do and truly believe nature heals!"
- "I’ve tried other drugs that didn’t work and I’ve heard very positive changes in brain chemistry from microdosing and guided psychedelics."
- "Hello, I was diagnosed with borderline personality about five months ago. I have struggled with alcoholism and depression most of my adult life. Fortunately, I was able to stop drinking a couple of years ago but the anger, sadness and chaotic relationships continued. About five months ago, I decided to see my first psychologist and she has helped me determine the root cause of all of my problems to be borderline personality disorder. DBT therapy takes years to master and doesn’t address what caused me to develop this disorder in the first place. I have recently begun reading about Psilocybin and think it might be a very good thing for me."
What questions have other patients asked about this trial?
- "1. How does the waitlist work?"
How many prior treatments have patients received?
| 0 | 50.0% |
| 3+ | 50.0% |
How responsive is this trial?
Typically responds via
| 100.0% | |
Average response time
- < 2 Days
Most responsive sites:
- University of Chicago: < 24 hours
References
- McMain, Shelley F., Tim Guimond, David L. Streiner, Robert J. Cardish, and Paul S. Links. 2012. “Dialectical Behavior Therapy Compared with General Psychiatric Management for Borderline Personality Disorder: Clinical Outcomes and Functioning over a 2-year Follow-up”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/appi.ajp.2012.11091416.
- Zanarini, Mary C., S. Charles Schulz, Holland C. Detke, Yoko Tanaka, Fangyi Zhao, Daniel Lin, Walter Deberdt, Ludmila Kryzhanovskaya, and Sara Corya. 2011. “A Dose Comparison of Olanzapine for the Treatment of Borderline Personality Disorder”. The Journal of Clinical Psychiatry. Physicians Postgraduate Press, Inc. doi:10.4088/jcp.08m04138yel.
- Schulz, S. Charles, Mary C. Zanarini, Anthony Bateman, Martin Bohus, Holland C. Detke, Quynh Trzaskoma, Yoko Tanaka, Daniel Lin, Walter Deberdt, and Sara Corya. 2008. “Olanzapine for the Treatment of Borderline Personality Disorder: Variable Dose 12-week Randomised Double-blind Placebo-controlled Study”. British Journal of Psychiatry. Royal College of Psychiatrists. doi:10.1192/bjp.bp.107.037903.
- Pascual, Juan Carlos, Joaquim Soler, Dolors Puigdemont, Rosario Perez-Egea, Thais Tiana, Enrique Alvarez, and Victor Perez. 2008. “Ziprasidone in the Treatment of Borderline Personality Disorder”. The Journal of Clinical Psychiatry. Physicians Postgraduate Press, Inc. doi:10.4088/jcp.v69n0412.
- Blum, Nancee, M.S.W., Don St. John M.A., P.A., Bruce Pfohl M.D., Scott Stuart M.D., Brett McCormick M.A., Jeff Allen Ph.D., Stephan Arndt Ph.D., and Donald W. Black M.D.. 2008. “Systems Training for Emotional Predictability and Problem Solving (STEPPS) for Outpatients with Borderline Personality Disorder: A Randomized Controlled Trial and 1-year Follow-up”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/appi.ajp.2007.07071079.
- Lieb, Klaus, Birgit Völlm, Gerta Rücker, Antje Timmer, and Jutta M. Stoffers. 2010. “Pharmacotherapy for Borderline Personality Disorder: Cochrane Systematic Review of Randomised Trials”. British Journal of Psychiatry. Royal College of Psychiatrists. doi:10.1192/bjp.bp.108.062984.
- Nickel, Marius K., M.D., Moritz Muehlbacher M.D., Cerstin Nickel M.D., Christian Kettler M.D., Francisco Pedrosa Gil M.D., Egon Bachler Ph.D., Wiebke Buschmann M.D., et al.. 2006. “Aripiprazole in the Treatment of Patients with Borderline Personality Disorder: A Double-blind, Placebo-controlled Study”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/ajp.2006.163.5.833.
- Gunderson J: Borderline Personality Disorder, 2nd ed. Washington, DC, American Psychiatric Press, 2000
- Nakao K, Gunderson JG, Phillips KA, Tanaka N: Functional impairment in personality disorders. J Pers Disord 1992; 6:24-31
- Linehan, Marsha M., Katherine Anne Comtois, Angela M. Murray, Milton Z. Brown, Robert J. Gallop, Heidi L. Heard, Kathryn E. Korslund, Darren A. Tutek, Sarah K. Reynolds, and Noam Lindenboim. 2006. “Two-year Randomized Controlled Trial and Follow-up of Dialectical Behavior Therapy Vs Therapy by Experts for Suicidal Behaviors and Borderline Personality Disorder”. Archives of General Psychiatry. American Medical Association (AMA). doi:10.1001/archpsyc.63.7.757.
- Zanarini, Mary C.. 2003. “Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD): A Continuous Measure of DSM-IV Borderline Psychopathology”. Journal of Personality Disorders. Guilford Publications. doi:10.1521/pedi.17.3.233.22147.
- Blum N, St John D, Pfohl B, Stuart S, McCormick B, Allen J, Arndt S, Black DW. Systems Training for Emotional Predictability and Problem Solving (STEPPS) for outpatients with borderline personality disorder: a randomized controlled trial and 1-year follow-up. Am J Psychiatry. 2008 Apr;165(4):468-78. doi: 10.1176/appi.ajp.2007.07071079. Epub 2008 Feb 15. Erratum In: Am J Psychiatry. 2008 Jun;165(6):777.
- Nickel MK, Muehlbacher M, Nickel C, Kettler C, Pedrosa Gil F, Bachler E, Buschmann W, Rother N, Fartacek R, Egger C, Anvar J, Rother WK, Loew TH, Kaplan P. Aripiprazole in the treatment of patients with borderline personality disorder: a double-blind, placebo-controlled study. Am J Psychiatry. 2006 May;163(5):833-8. doi: 10.1176/ajp.2006.163.5.833.
- Lieb K, Vollm B, Rucker G, Timmer A, Stoffers JM. Pharmacotherapy for borderline personality disorder: Cochrane systematic review of randomised trials. Br J Psychiatry. 2010 Jan;196(1):4-12. doi: 10.1192/bjp.bp.108.062984.
- Pascual JC, Soler J, Puigdemont D, Perez-Egea R, Tiana T, Alvarez E, Perez V. Ziprasidone in the treatment of borderline personality disorder: a double-blind, placebo-controlled, randomized study. J Clin Psychiatry. 2008 Apr;69(4):603-8. doi: 10.4088/jcp.v69n0412.
- Zanarini MC, Vujanovic AA, Parachini EA, Boulanger JL, Frankenburg FR, Hennen J. Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD): a continuous measure of DSM-IV borderline psychopathology. J Pers Disord. 2003 Jun;17(3):233-42. doi: 10.1521/pedi.17.3.233.22147. Erratum In: J Personal Disord. 2003 Aug;17(4):1 p following 369.
- Linehan MM, Comtois KA, Murray AM, Brown MZ, Gallop RJ, Heard HL, Korslund KE, Tutek DA, Reynolds SK, Lindenboim N. Two-year randomized controlled trial and follow-up of dialectical behavior therapy vs therapy by experts for suicidal behaviors and borderline personality disorder. Arch Gen Psychiatry. 2006 Jul;63(7):757-66. doi: 10.1001/archpsyc.63.7.757. Erratum In: Arch Gen Psychiatry. 2007 Dec;64(12):1401.
- 2023. "Psilocybin in Co-occuring Major Depressive Disorder and Borderline Personality Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05399498.
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