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New treatment option for Treatment Resistant Depression
Official title Psilocybin for Treatment-Resistant Depression in Autism
ClinicalTrials.gov ID: NCT06731621
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for treatment resistant depression.
Also referred to as Psilocybin-Assisted Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- We propose a first-of-its-kind open-label clinical trial to investigate the feasibility, tolerability, and safety of administering psilocybin in autistic adults with treatment-resistant depression (TRD). In this study, 20 participants (intellectually able and fluent-speech adults) with autism and co-occurring TRD will receive around 20 hours of manualized psychotherapy that has previously been used with psilocybin (Agin-Liebes et al., 2020).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Must be aged 18 to 65 years old;
- Must be deemed to have capacity to provide informed consent;
- Ability to read and communicate in English;
- Must sign and date the informed consent form;
- Stated willingness to comply with all study procedures;
You likely can't join if
- Pregnant as assessed by a urine pregnancy test or individual's that intend to become pregnant during the study or are breastfeeding;
- Treatment with another investigational drug or other intervention within 30 days of Screening (V1);
- The presence of an unstable seizure disorder as defined by having not been seizure-free for at least 6 months or anticonvulsant treatment has not...
- The presence of any clinically significant or unstable medical conditions, including cardiovascular, liver, kidney, pulmonary disease, presence of...
- Moderate or severe DSM-5 diagnosis of an alcohol or substance use disorder in the past 12 months;
- Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder, psychotic disorder (unless substance induced or due to a medical condition)...
See the full eligibility criteria
- Must be aged 18 to 65 years old;
- Must be deemed to have capacity to provide informed consent;
- Ability to read and communicate in English;
- Must sign and date the informed consent form;
- Stated willingness to comply with all study procedures;
- Intellectually able: Either 1) the participant has a previous report showing intelligence quotient (IQ) ≥ 70 on the General Abilities Index of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) or any other...
- Clinical diagnosis of autism spectrum disorder (ASD), based on the DSM-5 or ICD-11
- Primary DSM-5 diagnosis of non-psychotic MDD, single or recurrent, based on the Mini International Neuropsychiatric Interview (MINI) administered at the first screening visit (V1);
- Participants diagnosed with treatment-resistant depression defined as individuals with a baseline GRID-HAMD-17 score \> 14 and that have not responded to two or more separate trials of antidepressants at an adequate...
- Ability to take oral medication;
- Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 3 months prior to screening and agreement to use such a method during study participation;
- Individuals who are willing to taper off current antidepressant and antipsychotic medications for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and whose physician confirms that it is...
- A clean urine drug screen and negative urine pregnancy test (in females).
- Agreement to adhere to Lifestyle Considerations (see below) throughout study duration
- Pregnant as assessed by a urine pregnancy test or individual's that intend to become pregnant during the study or are breastfeeding;
- Treatment with another investigational drug or other intervention within 30 days of Screening (V1);
- The presence of an unstable seizure disorder as defined by having not been seizure-free for at least 6 months or anticonvulsant treatment has not been stable for at least 4 weeks;
- The presence of any clinically significant or unstable medical conditions, including cardiovascular, liver, kidney, pulmonary disease, presence of known congenital brain malformation, as per investigator assessment...
- Moderate or severe DSM-5 diagnosis of an alcohol or substance use disorder in the past 12 months;
- Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder, psychotic disorder (unless substance induced or due to a medical condition), bipolar I or II disorder, paranoid personality disorder, or neurocognitive...
- Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I or II disorder as determined by the family medical...
- Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension, low or labile blood pressure, recent myocardial infarction, cardiac...
- Substantial lifetime use (\>10 years total) or recent use (past 6 months) of ketamine, psychedelics, or MDMA and positive urine toxicological screen at Screening (V1) and Baseline (V2);
- Any other clinically significant physical illness, including chronic infectious diseases or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study...
- Have active suicidal ideation with intent and plan as determined by SBQ-ASC.
- Have initiated new psychotherapy within 12 weeks prior to Screening
- Contraindication to MR imaging or a previous history of claustrophobia. Lifestyle considerations: During this clinical trial, participants are asked to:
- Abstain from alcohol for 24 hours before the intervention or the day of the intervention (V3, V4).
- Abstain from the use of any prescribed opioids, benzodiazepines, or sleep aids (Z-drugs) within 12 hrs prior to the intervention (V3, V4) and for up to 6 hrs after administration.
- Abstain from any illicit drugs (e.g. cocaine, ecstasy/MDMA, hallucinogens) for the duration of the study.
- Abstain from any cannabinoids within 3 weeks prior to the intervention (V3, V4) and until the completion of the 2nd integrative therapy session (V6).
- Abstain from driving or operating heavy machinery for up to 24 hours after the intervention (V3, V4).
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.