Psilocybin in Co-occuring Major Depressive Disorder and Borderline Personality Disorder

Study Overview
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Brief Summary
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The primary objective of the study is to evaluate the safety and efficacy of psilocybin in adults with major depressive disorder (MDD) and borderline personality disorder (BPD).

Detailed Description
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The primary objective of the proposed study is to evaluate the safety and efficacy of psilocybin in adults with major depressive disorder (MDD) and borderline personality disorder (BPD). Ten subjects with MDD and BPD will receive a single 25 mg oral dose of psilocybin. The hypothesis to be tested is that psilocybin will result significant reduction in symptoms of both MDD and BPD after 1 week and sustained for 4 weeks compared to baseline (improvement in symptoms will be indicated by lower scores on established outcome measures of MDD and BPD symptoms that have been used in prior studies).

Official Title
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An Open Label Study of Single-Dose Psilocybin for Major Depressive Disorder With Co-occurring Borderline Personality Disorder

Conditions
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Borderline Personality Disorder, Major Depressive Disorder

Intervention / Treatment
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* Drug: Psilocybin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 Diagnosed with current major depressive disorder Montgomery-Asberg Depression Rating Scale (MADRS) score of > 20 Diagnosed with borderline personality disorder Borderline Personality Disorder Symptom Assessment Scale (BPD-SAS) score of > 20 Ability to understand and sign the consent form Exclusion Criteria: Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination Current pregnancy or lactation, or inadequate contraception in women of childbearing potential Illegal substance use based on urine toxicology screening (except cannabis use) Current or past history of bipolar I disorder, schizophrenia, or schizoaffective disorder Active substance use disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label treatment study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Psilocybin<br>Single 25 mg capsule oral dose of psilocybin | Drug: Psilocybin<br>* Psilocybin 25mg capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale (MADRS) | One of the co-primary outcome measures will be the change from baseline using the Montgomery-Asberg Depression Rating Scale (MADRS). The MADRS is a 10-item, clinician-administered scale that assesses depression symptoms during the last seven days. Each item is rated on a scale from 0 to 6, with 0 being normal/not present and 6 being extreme. | Baseline to Week 5 | 
| Borderline Personality Disorder Symptom Assessment Scale (BPD-SAS) | One of the co-primary outcome measures will be the change from baseline using the Borderline Personality Disorder Symptom Assessment Scale (BPD-SAS). The BPD-SAS covers a two-week time frame and each of the nine criteria, each representing symptoms of BPD, for BPD is rated on a five-point anchored rating scale of 0-4, with 0 representing no symptoms and 4 representing extreme symptoms. | Baseline to Week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression - Severity scale (CGI-S) | A clinician administered, single item scale measuring global severity of psychiatric illness. The scale itself assesses overall disorder severity on a scale from 1 to 7 with 1 being not at all and 7 being among the most severe cases | Baseline to Week 5 | 
| Clinical Global Impression - Improvement scale (CGI-I) | A clinician administered, single item scale measuring overall improvement of global severity of psychiatric illness. The scale itself assesses overall disorder improvement on a scale from 1 to 7 with 1 being Very much improved and 7 being Very much worse | Week 2 to Week 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPD, MDD, Psilocybin