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."
Psilocybin in Co-occuring Major Depressive Disorder and Borderline Personality Disorder
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).
Condition or Disease
- Borderline Personality Disorder
- Major Depressive Disorder
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Not yet recruiting |
| Study results: | No Results Available |
| Age: | 18 Years to 65 Years |
| Enrollment: | 10 (ESTIMATED) |
| Funded by: | Other |
| Allocation: | N/A |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Oct 01, 2023 | ESTIMATED |
|---|---|---|
| Primary Completion: | Jul 01, 2024 | ESTIMATED |
| Completion Date: | Aug 01, 2024 | ESTIMATED |
| Study First Posted: | Jun 01, 2022 | ACTUAL |
| Last Updated: | Sep 20, 2023 |
Sponsors / Collaborators
Location
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).
Participant Groups
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Single 25 mg capsule oral dose of psilocybin
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 65 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
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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 Outcomes
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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"
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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"
More Details
| NCT Number: | NCT05399498 |
|---|---|
| Other IDs: | IRB22-0272 |
| Study URL: | https://clinicaltrials.gov/study/NCT05399498 |
Last updated: Sep 29, 2023