Psilocybin-assisted psychotherapy for Generalised Anxiety Disorder

Phase 2

Active, not recruiting

• Conditions: Generalised Anxiety Disorder; Mental Health - Anxiety

• Registration Number: ACTRN12621001358831
• Lead Sponsor: Monash University

Brief Summary

Study not complete

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-08
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

*Adults experiencing severe GAD.
*Proficiency in English.
*Provide a contact (relative, spouse, close friend or other Support Person) who can transport and provide support to participant following two or three experimental sessions.
*Taper and cease of certain excluded medications is deemed appropriate, agreeable, and under supportive care, and successful following confirmation of preliminary enrolment. Note, prospective participants are not required to taper and cease prior to preliminary enrolment.
*Agree to all study-related requirements.

Exclusion Criteria

*Contraindicated medical conditions including cardiovascular conditions, major CNS disease, hepatic dysfunction, hypercalcaemia risk, epilepsy/seizures, renal insufficiency, diabetes, and hypothyroidism.
*Weigh less than 48 kilograms or BMI < 17.
*Are pregnant or nursing, or able to become pregnant and are not practicing permanent or double-barrier birth control methods.
*Taking a contraindicated medication that cannot be ceased for an appropriate length of time during the trial.
*Extremely severe depression, anxiety, suicidality or other psychiatric symptoms that would warrant hospitalisation, as determined by the screening psychiatrist in a clinical interview.
*Current or past history of meeting DSM-5 criteria for certain excluded psychiatric indications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified