Swinburne Three-dose Psilocybin Assisted Psychotherapy (3PAP): a clinical trial of 2 vs 3 doses of psilocybin-assisted psychotherapy vs psychotherapy with placebo for Treatment-Resistant Depressio

Phase 2

Recruiting

• Conditions: Treatment-Resistant Depression; Mental Health - Depression

• Registration Number: ACTRN12623000667617
• Lead Sponsor: Swinburne University of Technology, Hawthorn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-21
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Adults aged 18 to 65 years.
- Those currently experiencing major depressive disorder (DSM-5) as determined by the SCID-5.
- Those with current moderate to severe depression according to the MADRS.
- Treatment-resistance using criteria adapted from current literature of research in major depression.
- Under the care of a psychiatrist, psychologist, physician, or GP.
- Proficiency in English.
- Safe tapering and wash-out of current antidepressant pharmacotherapy prior to baseline assessment, as confirmed by treating GP, psychiatrist, or physician.
- Abstinence from illicit or extra-medical drug and alcohol use for at least 2 days prior to each dose session.
- Participants who agree to have their drug dosing sessions recorded to video for treatment fidelity and clinical supervision within the study team.
- Participants who are able to swallow tablets.

Exclusion Criteria

Key General Medical Exclusion Criteria:
- Patients in treatment in another clinical trial involving an investigational product.
- Any disorder with known CNS involvement, or other major CNS disease.
- Hepatic dysfunction.
- Known conditions putting participant at risk for hypercalcaemia,
- Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), TIA in the last 6 months, stroke, or cerebrovascular disease, peripheral or pulmonary vascular disease.
- A diagnosis of epilepsy or previous seizures.
- Renal insufficiency.
- Insulin-dependent diabetes.
- Females who are pregnant or nursing or are trying to get pregnant, or become pregnant during the study.
- Current hypothyroidism.
- Weight less than 40 kg.
- Contraindicated medication (SSRIs, SNRIs, MAOIs), and either 1) do not wish to be tapered off this medication, or 2) it is deemed by trial psychiatrists or the participant’s usual treatment team that tapering the participant off their current medication would be inappropriate.
- Use of any illicit or extra-medical drugs or alcohol within the 2 days prior to each psilocybin dosing.
- Current use of any potent metabolic inducers or inhibitors
- Significant, uncorrected visual impairments (to ensure that they can read all study material).

Key Psychiatric Exclusion Criteria:
- Current or past history of meeting DSM-5 criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), Bipolar I or II Disorder, or Mania.
- First degree relative with diagnosed Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), Bipolar I or II Disorder or Mania.
- Currently meets DSM-5 criteria for Dissociative Disorder, Anorexia Nervosa, Bulimia Nervosa, or any psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
- Unable to give adequate informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified