RECRUITING

Psilocybin-Assisted Therapy in Treatment-Resistant Depression

Conditions

Refractory Depression Treatment Resistant Depression psilocybin psychedelic psychedelic-assisted therapy treatment-resistant depression TRD depression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are: * Does psilocybin with assisted therapy help improve symptoms for people with depression? * How long do the effects of this treatment last? Participants will: * Take part in a couple of screening and preparation visits. * Be given psilocybin in one or two treatment sessions. * Attend a series of follow-up sessions over the following year. * Complete forms and surveys to test how their symptoms have changed and what they thought of their experience. Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants.

Official Title

Induction Protocol for Psilocybin-Assisted Therapy in Treatment-Resistant Depression (TRD): A Pilot Study

Quick Facts

Study Start:2024-04-19

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06303739

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Provision of signed and dated informed consent form. * Willingness to comply with all study procedures and availability for the study. * Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-V) diagnosis of major depressive disorder. * Currently experiencing a major depressive episode, lasting at least 3 months * Failure to respond or inability to tolerate at least 2 guideline-concordant pharmacological treatments from different pharmacologic classes during the current major depressive episode * Good health evidenced by medical history and routine lab tests * No central nervous system (CNS) or neurocognitive impairment * Ability to take oral medication and to follow to the psilocybin-assisted therapy protocol * Identified support person to accompany patient home after dosing * Use of effective contraception throughout the study by those with child-bearing potential * Use of condoms or other effective contraceptive methods by males with reproductive potential * Fully vaccinated and up to date on vaccination against COVID-19, as defined by Center for Disease Control guidelines * Following Lifestyle Considerations throughout study (no nicotine containing products in clinical unit, refrain from operating heavy machinery for the duration of treatment day, no more than two servings 8 hours prior to treatment, no psychoactive drugs 72 hours before treatment, refrain from consuming foods that would interfere with drug absorption, minimize interaction with household immunocompromised contacts)	* Family history (first- or second-degree relatives) or diagnosis of bipolar disorder with psychotic features, schizophrenia, schizoaffective disorder, hallucinogen-induced psychosis, anti-social personality disorder, or other psychotic disorder. * Borderline personality disorder, defined by DSM-V criteria, that in the judgement of the Investigator is likely to complicate the assessment of clinical response to study treatments or limits the patient's ability to comply with study procedures. * Alcohol or other substance use disorder (except tobacco/nicotine) that has been active within the 6 months prior to enrollment. * Recent use (within past 6 months) of esketamine, ketamine or classic hallucinogens (psilocybin-containing mushrooms or LSD) or use of psychedelics more than 10 times in lifetime. * Participants with active suicidal ideation or plan with a Columbia Suicide Severity Rating Scale (C-SSRS) score greater than or equal to 4. * Current active self-injurious behavior, requiring medical attention or per investigator discretion. * Diagnosis of Obsessive-compulsive disorder or post-traumatic stress disorder. * Within 72 hours of psilocybin administration, use of nicotine, alcohol, or other controlled substances. * Current delirium, dementia, amnestic disorder, or other cognitive disorders. * Any current or past medical or neurological illness (including chronic pain syndromes and/or history of cerebrovascular event (excluding migraine)) that, in the opinion of the investigator, may confound the interpretation of study assessments * Known allergic reactions to components of psilocybin. * Medically instability at screening, including hepatic, renal, circulatory, cardiac (arrhythmia, uncontrolled hypertension, systolic BP \> 140 mmHg or diastolic BP \> 90 mmHg, abnormal QTc), pulmonary or CNS (seizure disorder or treatment with antiepileptic drugs) impairment. * Current pregnancy or lactation. * Febrile illness in last 3 weeks. * Current use or use within 4 weeks of psilocybin administration of Monoamine oxidase inhibitors (MAOIs), alcohol dehydrogenase inhibitors and antipsychotics (concomitant medications will be allowed per investigator discretion). * Current treatment with buproprion greater than 300mg/day. * Current use of tramadol. * Prior participation in psilocybin-assisted therapy trial and or regular use of hallucinogens * Treatment with another investigational drug or other intervention during study period.

Inclusion Criteria

Exclusion Criteria

* Provision of signed and dated informed consent form.
* Willingness to comply with all study procedures and availability for the study.
* Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-V) diagnosis of major depressive disorder.
* Currently experiencing a major depressive episode, lasting at least 3 months
* Failure to respond or inability to tolerate at least 2 guideline-concordant pharmacological treatments from different pharmacologic classes during the current major depressive episode
* Good health evidenced by medical history and routine lab tests
* No central nervous system (CNS) or neurocognitive impairment
* Ability to take oral medication and to follow to the psilocybin-assisted therapy protocol
* Identified support person to accompany patient home after dosing
* Use of effective contraception throughout the study by those with child-bearing potential
* Use of condoms or other effective contraceptive methods by males with reproductive potential
* Fully vaccinated and up to date on vaccination against COVID-19, as defined by Center for Disease Control guidelines
* Following Lifestyle Considerations throughout study (no nicotine containing products in clinical unit, refrain from operating heavy machinery for the duration of treatment day, no more than two servings 8 hours prior to treatment, no psychoactive drugs 72 hours before treatment, refrain from consuming foods that would interfere with drug absorption, minimize interaction with household immunocompromised contacts)

* Family history (first- or second-degree relatives) or diagnosis of bipolar disorder with psychotic features, schizophrenia, schizoaffective disorder, hallucinogen-induced psychosis, anti-social personality disorder, or other psychotic disorder.
* Borderline personality disorder, defined by DSM-V criteria, that in the judgement of the Investigator is likely to complicate the assessment of clinical response to study treatments or limits the patient's ability to comply with study procedures.
* Alcohol or other substance use disorder (except tobacco/nicotine) that has been active within the 6 months prior to enrollment.
* Recent use (within past 6 months) of esketamine, ketamine or classic hallucinogens (psilocybin-containing mushrooms or LSD) or use of psychedelics more than 10 times in lifetime.
* Participants with active suicidal ideation or plan with a Columbia Suicide Severity Rating Scale (C-SSRS) score greater than or equal to 4.
* Current active self-injurious behavior, requiring medical attention or per investigator discretion.
* Diagnosis of Obsessive-compulsive disorder or post-traumatic stress disorder.
* Within 72 hours of psilocybin administration, use of nicotine, alcohol, or other controlled substances.
* Current delirium, dementia, amnestic disorder, or other cognitive disorders.
* Any current or past medical or neurological illness (including chronic pain syndromes and/or history of cerebrovascular event (excluding migraine)) that, in the opinion of the investigator, may confound the interpretation of study assessments
* Known allergic reactions to components of psilocybin.
* Medically instability at screening, including hepatic, renal, circulatory, cardiac (arrhythmia, uncontrolled hypertension, systolic BP \> 140 mmHg or diastolic BP \> 90 mmHg, abnormal QTc), pulmonary or CNS (seizure disorder or treatment with antiepileptic drugs) impairment.
* Current pregnancy or lactation.
* Febrile illness in last 3 weeks.
* Current use or use within 4 weeks of psilocybin administration of Monoamine oxidase inhibitors (MAOIs), alcohol dehydrogenase inhibitors and antipsychotics (concomitant medications will be allowed per investigator discretion).
* Current treatment with buproprion greater than 300mg/day.
* Current use of tramadol.
* Prior participation in psilocybin-assisted therapy trial and or regular use of hallucinogens
* Treatment with another investigational drug or other intervention during study period.

Contacts and Locations

Study Contact

Brittania Ricketts

CONTACT

9849741004

PilotPAT_study@med.unc.edu

Robert K McClure, MD

CONTACT

9199286381

robert_mcclure@med.unc.edu

Principal Investigator

Robert K McClure, MD

PRINCIPAL_INVESTIGATOR

Director of Interventional Psychiatry

Study Locations (Sites)

UNC Chapel Hill Medical Center

Chapel Hill, North Carolina, 27514

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Robert K McClure, MD, PRINCIPAL_INVESTIGATOR, Director of Interventional Psychiatry

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-19

Study Completion Date2026-09

Study Record Updates

Study Start Date2024-04-19

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

psilocybin
psychedelic
refractory depression
psychedelic-assisted therapy
treatment-resistant depression
TRD
depression

Additional Relevant MeSH Terms

Refractory Depression
Treatment Resistant Depression