Clinical trial • Phase II • Psychiatry

DRY EXTRACT FROM PSILOCYBE CUBENSIS (15-25:1), EXTRACTION SOLVENT: METHANOL for Anorexia nervosa

Phase II trial of DRY EXTRACT FROM PSILOCYBE CUBENSIS (15-25:1), EXTRACTION SOLVENT: METHANOL for Anorexia nervosa.

Overview

Standard Treatment as Usual (TAU)-controlled Phase II trial across 1 site in Sweden.

Recruits 40 paediatric patients.

Pregnancy Exclusion: Refusal of birth control during until primary endpoint.
Vulnerable Population: Participants include minors aged 16-17. The registry does not mark a vulnerable population (isVulnerablePopulationSelected:false) but parental/guardian consent materials are provided (document titles include 'Samtycke psiAN - foralder' and other parent consent forms), and participant information and consent forms for participants are present. Specific assent/consent age-handling is indicated by the presence of parent/guardian consent documents.

{"criterion_text":"- Anorexia Nervosa as defined by DSM-5."}
{"criterion_text":"- Age 16-35"}
{"criterion_text":"- Ongoing stable contact with an outpatient psychiatric unit."}
{"criterion_text":"- BMI >16."}
{"criterion_text":"- Have experienced at least one period of remission (minimum BMI 17) followed by a relapse."}

{"criterion_text":"- Psychosis, bipolar disorder or substance use disorder"}
{"criterion_text":"- Blood or needle phobia."}
{"criterion_text":"- Unable to follow study protocol."}
{"criterion_text":"- Presence of metal pieces in the body (contraindicated by fMRI)."}
{"criterion_text":"- Cardiovascular conditions, epilepsy, diabetes mellitus"}
{"criterion_text":"- Refusal of birth control during until primary endpoint."}
{"criterion_text":"- Previous use of classical psychedelics"}
{"criterion_text":"- Ongoing medications that would interfere negatively with the study drug."}
{"criterion_text":"- Family history of psychosis or bipolar disorder."}
{"criterion_text":"- Positive drug tests"}
{"criterion_text":"- Suicidal intent."}
{"criterion_text":"- Allergy or intolerance to drug content."}
{"criterion_text":"- Any other clinically significant medical condition that, in the investigator’s opinion, may pose a risk to the participant or interfere with study results."}

{"endpoint_text":"- Incidence of adverse events (AEs) and serious adverse events (SAEs) during the trial period.","definition_or_measurement_approach":""}

{"endpoint_text":"- General Anxiety (GAD-2)","definition_or_measurement_approach":""}
{"endpoint_text":"- Patient Health Questionnaire (PHQ-2)","definition_or_measurement_approach":""}
{"endpoint_text":"- Experiences in Close Relationships – (ECR–RS)","definition_or_measurement_approach":""}
{"endpoint_text":"- Life Satisfaction (LS)","definition_or_measurement_approach":""}
{"endpoint_text":"- Positive & Neg Affect (PANAS)","definition_or_measurement_approach":""}
{"endpoint_text":"- Harmony in Life (HILS)","definition_or_measurement_approach":""}
{"endpoint_text":"- Self-compassion (Short SCS)","definition_or_measurement_approach":""}
{"endpoint_text":"- Ten Item Pers Inv (TIPI)","definition_or_measurement_approach":""}
{"endpoint_text":"- AN symptom severity (EDE)","definition_or_measurement_approach":""}
{"endpoint_text":"- Response: A clinically significant improvement in weight and psychological symptoms during the treatment period.","definition_or_measurement_approach":""}
{"endpoint_text":"- Remission: The achievement and maintenance of weight restoration and psychological well-being, with no significant symptoms of anorexia nervosa.","definition_or_measurement_approach":""}
{"endpoint_text":"- Relapse: Defined as a composite outcome during the 6-month follow-up period","definition_or_measurement_approach":""}

Planned Sample Size: 40
Recruitment Window Months: 20
Consent Approach: Participant informed consent is documented; there are dedicated participant information and consent forms and separate parental consent forms (document titles: 'Forskningspersonsinformation', 'Samtycke psiAN - foralder', 'Samtycke_psiAN_deltagare'). For minors (age 16-17) parent/guardian consent materials are provided. Languages of the documents are not explicitly stated in the available metadata.

Investigational Product Name: PEX010 (PRD12057625)
Active Substance: DRY EXTRACT FROM PSILOCYBE CUBENSIS (15-25:1), EXTRACTION SOLVENT: METHANOL
Modality: Other
Routes Of Administration: Oral
Route: Oral
Starting Dose: 25 mg
Dose Levels: 25 mg
Frequency: Two doses: 25 mg given once, repeated one month later
Maximum Dose: 50 mg

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