Psilocybin for Treatment-Resistant Depression in... — Clinical Trial Details

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

Inclusion Criteria:
Autistic adult, ages 18–65
Must be deemed to have capacity to provide informed consent
Must sign and date the informed consent form
Willingness to comply with all study procedures
Intellectually able: either documented IQ ≥70 on WAIS-IV GAI or equivalent, or >10th percentile on nine-item RSPM
Ability to read and communicate in English sufficient for consent and questionnaires
Primary DSM-5 diagnosis of non-psychotic MDD (single or recurrent) based on SCID-5-CV at screening
Treatment-resistant depression defined as baseline GRID-HAMD-17 > 14 and non-response to ≥2 adequate antidepressant trials (no upper limit on failures)
Ability to take oral medication
Individuals capable of becoming pregnant must use highly effective contraception for ≥3 months prior to screening and during participation
Willingness to taper off current antidepressant and antipsychotic medications for a minimum of 2 weeks (or longer as required) prior to baseline with physician approval
Agreement to adhere to lifestyle considerations during study

Exclusion Criteria

Exclusion Criteria:
Pregnant or breastfeeding or intending to become pregnant during the study
Treatment with another investigational drug or intervention within 30 days of screening
Unstable seizure disorder (not seizure-free for ≥6 months or unstable anticonvulsant treatment <4 weeks)
Any clinically significant or unstable medical condition (cardiovascular, liver, kidney, pulmonary disease, congenital brain malformation) per investigator assessment
Moderate or severe DSM-5 alcohol or substance use disorder in past 12 months
Any DSM-5 lifetime diagnosis of schizophrenia-spectrum disorder, psychotic disorder (unless substance-induced or medical), bipolar I/II, paranoid personality disorder, or neurocognitive disorder
Any first-degree relative with schizophrenia-spectrum disorder, psychotic disorder (unless substance-induced or medical), or bipolar I/II disorder
Contraindication to psilocybin (drug allergy, recent stroke, uncontrolled or labile BP, recent MI, arrhythmia, severe CAD, moderate–severe renal or hepatic impairment)
Substantial lifetime use (>10 years) or recent use (past 6 months) of ketamine, psychedelics, or MDMA
Any other clinically significant physical illness that may interfere with study or pose risk
Active suicidal ideation with intent and plan as determined by SBQ-ASC
Currently undergoing psychotherapy or received psychotherapy within 12 weeks prior to screening
Contraindication to MRI (metal implants, pacemaker, aneurysm clips, metallic tattoos on head, history of claustrophobia)

Company

Product

Legal

Psilocybin for Treatment-Resistant Depression in Autism With Pre-Post Brain and Cognitive Measurement to Understand Mechanisms (PAT-DA)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Open-label

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators