Psilocybin-Assisted Therapy in Treatment-Resistant Depression

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Mar 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of psilocybin-assisted therapy to see if it can help people with treatment-resistant depression, which means their depression has not improved with other treatments. The main goals are to find out if psilocybin, a natural substance found in certain mushrooms, combined with therapy can reduce depression symptoms and how long these benefits might last. Participants will go through a couple of preparation visits, receive psilocybin in one or two sessions, and then attend follow-up sessions for a year to share how they feel and complete surveys about their experiences.

To join the trial, participants should be between 18 and 75 years old, have a diagnosis of major depressive disorder, and have not found relief from at least two different depression medications. They should be in good health, be able to take oral medications, and have someone to support them after the treatment sessions. It's important to know that certain conditions, like a history of severe mental illness or substance abuse, may prevent someone from participating. This trial is currently looking for volunteers, and all participants will have a chance to contribute to finding new ways to treat depression.

Gender

ALL

Eligibility criteria

• Inclusion 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)
• Exclusion Criteria:
• • 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 4 weeks) of esketamine, ketamine or classic hallucinogens (psilocybin-containing mushrooms or LSD) or use of psychedelics within the past 6 months or 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.