ISRCTN14487299
Active, not recruiting
Phase 2
A Phase IIb multicentre, randomised, double-blind, two-arm trial comparing the efficacy and safety of 25 mg psilocybin plus psychological support versus 5 mg psilocybin plus psychological support in adults with severe generalized anxiety disorder (GAD) (PSiGAD2)
Incannex Healthcare Limited0 sites96 target enrollmentSeptember 25, 2024
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Generalised anxiety disorder
- Sponsor
- Incannex Healthcare Limited
- Enrollment
- 96
- Primary Endpoint
- The efficacy of two doses of 25 mg psilocybin with psychological support versus two doses of 5 mg psilocybin with psychological support in the reduction of GAD symptoms in participants with severe GAD (who may or may not be taking concurrent selective serotonin reuptake inhibitor (SSRI) antidepressant). This will be calculated by assessing the change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at week 8, irrespective of treatment discontinuation.
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18 - 70 years
- •Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)/International Classification of Diseases 11th Revision (ICD-11) defined GAD as the primary diagnosis, with severity indicated by a HAM-A score >25
- •Any sex or gender
- •Body Mass Index 18 - 35 kg/m²
- •Medically suitable as determined by screening including a past medical history, family history, drug history, social history, physical examination and investigations, including an electrocardiogram (EEG) and blood tests.
- •Refrain from taking contraindicated or excluded medications, including herbal, complementary or over-the-counter medications, or have safely tapered and washed out from excluded medications in accordance with the washout period specified in the protocol.
Exclusion Criteria
- •Any clinically significant, untreated or unstable illness (e.g., hepatic, renal or cardiovascular functions)
- •Type 1 diabetes or insulin dependent type 2 diabetes
- •A diagnosis of epilepsy or at significant risk of seizures based on medical history
- •Positive urine drug test for psychoactive substances at in-clinic screening visit or dosing visits
- •Positive alcohol breathalyser test at the in-clinic screening visit or dosing visits
- •Female participants who are pregnant, breastfeeding or of childbearing potential who are unwilling or unable to use a highly effective method of contraception
- •Participation in another clinical trial of an investigational drug within 30 days or 5 half-lives of the drug (whichever is longest) prior to screening
- •Allergy, hypersensitivity or other Adverse Reaction (AR) to previous use of psilocybin, other hallucinogens, rescue medication and their excipients microcrystalline cellulose
- •Anyone with organic brain injury
- •Treatment with any other antidepressant medication other than a currently prescribed permitted SSRI which must be a stable dose (constant for at least 6 months with no plan to increase)
Outcomes
Primary Outcomes
The efficacy of two doses of 25 mg psilocybin with psychological support versus two doses of 5 mg psilocybin with psychological support in the reduction of GAD symptoms in participants with severe GAD (who may or may not be taking concurrent selective serotonin reuptake inhibitor (SSRI) antidepressant). This will be calculated by assessing the change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at week 8, irrespective of treatment discontinuation.
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