Opening up

Phase 1

Not yet recruiting

• Conditions: obsessive-compulsive disorder; body dysmorphic disorder; anorexia nervosa; Mental Health - Other mental health disorders; Mental Health - Anxiety

• Registration Number: ACTRN12624001160527
• Lead Sponsor: Swinburne University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-24
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

i)Adults aged 18 to 65 years.ii)Primary diagnosis of OCD, BDD or AN according to the DSM-5, determined by Structured Clinical Interview for DSM-5 Disorder (SCID-5), The Body Dysmorphic Disorder Diagnostic Module (BDD-DM) and Eating Disorder Examination (EDE).iii)Moderate to severe symptom severity indicated as a score 18 or greater on the YBOCS, 20 or greater on the BDD-YBOCS, 3 or greater on the shape and/or weight subscales of the EDE.iv)Treatment resistance; defined as 1-year of illness with continuing symptoms for at least 6-months despite adequate engagement in conventional interventions for the condition. Specifically, conventional therapies for each condition are defined as: OCD: a course of selective serotonin reuptake inhibitors (SSRIs) and at least one course of cognitive behavioural therapy (CBT) which must include exposure and response prevention (ERP) (Pallanti and Quercioli, 2006).BDD: two courses of psychotherapy and/or pharmacology treatment, including at least one course of cognitive behavioural therapy (CBT), adequatea course of SSRIs or serotonin-norepinephrine reuptake inhibitor (SNRI).AN: a course of SSRIs or SNRIs, and at least one in-patient admission or day patient program.v)Illness duration of at least 1- year vi)Absence of delusionality as indicated by a total score <18, and a score of <4 on the delusionality sub-scale on the BABS vii)Absence of mania symptoms (only minor) as indicated by a score <20 on the YMRSviii)If currently taking serotonergic antidepressants or atypical antipsychotics that block 5HT2A receptors, which can interfere with the mechanism of action of psilocybin, agree to, and can be, appropriately tapered off such concomitant medication with clinical team support.ix)Under the care of a psychiatrist, psychologist, physician, or GP.x)Proficient in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent. xi)Participants who agree to be abstinent from illicit or extra-medical drug and alcohol use for at least 2 days prior to each psilocybin dosing.xii)Participants who agree to have their drug dosing sessions recorded to video for treatment fidelity and clinical supervision within the study team.xiii)Utilising effective contraception if female and of childbearing agexiv)Capacity to provide adequate inform consent; demonstrated by an estimated IQ >79 assessed by the Weschler Abbreviated Scale of Intelligence (WASI) to ensure that study instructions can be understood, and by a revised version of the Evaluation to sign an informed consent document for research to ensure appropriate understanding of trial requirements (DeRenzo et al., 1998).

Exclusion Criteria

Psychiatric exclusions i)Lifetime history of serious suicide attempts requiring hospitalisation or current suicidal ideation with intent warranting immediate hospitalisation. ii)Current or past history of psychosis; DSM-5 criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), Bipolar I or II Disorder or Mania, determined by medical history and MINI assessment.iii)First degree relative with diagnosed Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), Bipolar I or II Disorder or Mania.iv)Presence of significant neurodevelopmental disorder (e.g., ADHD, autism, unremitting Tourette’s syndrome) that would reasonably impact the therapeutic effect of psilocybin. v)Currently meets DSM-5 criteria for Dissociative Disorder, Bulimia Nervosa, or significant personality disorder judged to be incompatible with establishment of rapport or safe exposure to psilocybin, determined by clinical interview.vi)Any current personal or situational factors that, in the opinion of the research team, might interfere with participation (for example, lacking social support, lacking a stable living situation, current domestic violence, or other ongoing trauma). vii)A history of childhood trauma or other factors leading to a complex case of OCD, BDD, or AN. General medical exclusions i)Any disorder with known CNS involvement or disease, including seizuresii)Hepatic dysfunction as indicated by the following values: iii)-- GGT > 3 x ULN (upper limit of norm)iv)-- AST > 3 x ULNv)-- ALT > 3 x ULNvi)-- Tot Bili > 3.0 mg/dL vii)Known conditions putting participant at risk for hypercalcaemia, Cushing's syndrome, hypoglycaemia, syndrome of inappropriate antidiuretic hormone secretion, or carcinoid syndrome. viii)Cardiovascular conditions: uncontrolled hypertension (Systolic >140 and diastolic >90), 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 (no active claudication). This could include patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440 ms for men and above 470 ms for women).ix)Renal insufficiency (creatinine clearance < 40 mL/min using the Cockcroft and Gault equation).x)Insulin-dependent diabetes; if taking oral hypoglycaemic agents only excluded if they also have a history of hypoglycaemia.xi)Females who are pregnant or nursing or are trying to get pregnant, or become pregnant during the study.xii)Current hypothyroidism not responsive to treatment or untreated hypothyroidism.xiii)Patients who weigh less than 40 kg or have a BMI <16 kg/m2.xiv)Medical instability as indicated by significant weight loss (>3 kg) during screening period, orthostatic heart rate or blood pressure.xv)Long-acting opioid pain medications (e.g., oxycodone sustained release, morphine sustained release -- which are usually taken at 12-hour intervals) will be allowed if the last dose occurred at least 6 hours before psilocybin administration; such medication will not be taken again until at least 6 hours after psilocybin administration. xvi)Macro-dose (i.e., dose large enough to have perceivable hallucinogenic/psychedelic effects) of any hallucinogen or psychedelic (including psilocybin, MDMA, LSD, mescaline, DMT, and other similar ha

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obsessive-compulsive symptom severity (OCD participants)[Yale Brown Obsessive Compulsive Scale (YBOCS)- total score Baseline and 8-week post-baseline. ];Body-dysmorphic symptom severity (BDD participants)[Body Dysmorphic Disorder- Yale Brown Obsessive Compulsive Scale (BDD-YBOCS)- total score Baseline and 8-week post-baseline. ];Anorexia nervosa symptom severity (AN participants)[Eating disorder Examination Questionnaire (EDE)- severity score Baseline and 8-week post-baseline. ]