Borderline Personality Disorder, Major Depressive Disorder
Conditions
Keywords
BPD, MDD, Psilocybin
Brief summary
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
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).
Interventions
DRUGPsilocybin
Psilocybin 25mg capsule
Sponsors
Usona Institute
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label treatment study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | Baseline to Week 5 | 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. |
| Borderline Personality Disorder Symptom Assessment Scale (BPD-SAS) | Baseline to Week 5 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression - Severity scale (CGI-S) | Baseline to Week 5 | 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 |
| Clinical Global Impression - Improvement scale (CGI-I) | Week 2 to Week 5 | 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 |
Countries
United States
Outcome results
None listed