Generalised anxiety disorder Mental and Behavioural Disorders
Conditions
Interventions
This is a randomised, double-blind trial with two treatment arms, comparing the efficacy and safety of 5 mg psilocybin plus psychological support with 25 mg psilocybin with psychological support in ad
Sponsors
Incannex Healthcare Limited
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 70 years 2. 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 3. Any sex or gender 4. Body Mass Index 18 - 35 kg/m² 5. 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. 6. 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
Exclusion criteria: 1. Any clinically significant, untreated or unstable illness (e.g., hepatic, renal or cardiovascular functions) 2. Type 1 diabetes or insulin dependent type 2 diabetes 3. A diagnosis of epilepsy or at significant risk of seizures based on medical history 4. Positive urine drug test for psychoactive substances at in-clinic screening visit or dosing visits 5. Positive alcohol breathalyser test at the in-clinic screening visit or dosing visits 6. Female participants who are pregnant, breastfeeding or of childbearing potential who are unwilling or unable to use a highly effective method of contraception 7. 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 8. Allergy, hypersensitivity or other Adverse Reaction (AR) to previous use of psilocybin, other hallucinogens, rescue medication and their excipients microcrystalline cellulose 9. Anyone with organic brain injury 10. 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) 11. Diagnosed with or having a first degree-relative family history of any of the following psychiatric disorders: schizophrenia or prodromal symptoms, any bipolar disorder, or other psychotic disorder as assessed during screening 12. Any history of suicide attempts or behaviours as indicated by reporting "yes" on any item of the Suicide Behaviour Section of the Columbia Suicide Severity Rating Scale (C-SSRS) within the last 5 years 13. History of suicidal ideation with some intent to act within the last 12 months prior to screening; the participant scores "yes" on item four or item five of the Suicidal Ideation section of the C-SSRS 14. Judged to be of high suicide or self-harm risk following psychological assessment at screening or baseline 15. Judged to be unfit for psilocybin-assisted therapy based on assessments made during psychological support sessions prior to first dosing session 16. Current or recent treatment with prohibited medications 17. History of hallucinogen use disorder, or any use in the past 1 year, or >25 lifetime uses 18. History of electroconvulsive treatment (ECT) or transcranial magnetic stimulation treatment, ketamine, or vagal nerve stimulation 19. Current (within 12 months) alcohol or drug abuse identified as moderate or severe during screening through medical history and the Mini International Neuropsychiatric Interview (MINI) 7.0.2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in GAD symptoms measured using Generalised Anxiety Disorder 7-item Scale (GAD-7) from baseline to weeks 4, 8, 11, 20 and 29. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of “not at all,” “several days,” “more than half the days,” and “nearly every day,” respectively, and then adding together the scores for the seven questions. GAD-7 total score for the seven items ranges from 0 to 21, with scores of 5, 10, and 15 representing cut-points for mild, moderate, and severe anxiety, respectively. 2. Change in GAD symptoms measured using HAM-A from baseline to weeks 3, 4, 7, 11, 20 and 29. Each item is scored on a basic numeric scoring of 0 (not present) to 4 (severe): >17/56 is taken to indicate mild anxiety; 25–30/56 is considered moderate–severe. 3. Rates of GAD clinical response (>50% reduction in baseline HAM-A) and remission (>7 on HAM-A) at weeks 3, 4, 8, 11, 20 and 29. 4. Change in impairment of functioning via the change in Sheehan Disability Scale (SDS) from baseline to weeks 4, 8, 11, 20 and 29. Respondents are asked to indicate how much their symptoms have disrupted their regular activities over the past week, and each subscale can be scored independently or combined into a single total score representing a global impairment rating, ranging from 0 to 30, with higher scores indicative of significant functional impairment. Subscale scores greater than 5 suggest impairment in that subscale area. 5. Change in satisfaction with quality of life via change in Warwick–Edinburgh Mental Well-being Scale (WEMWBS) from baseline to weeks 4, 8, 11, 20 and 29. The scale is scored by summing responses to each item answered on a 1 to 5 Likert scale. The minimum scale score is 14 and the maximum is 70. 6. Change in loss of workplace productivity via the change in Lost Workplace Productivity (LWP) measure from baseline to weeks 4, 8, 11, 20 and 29. Lost productivity is calculated as follows: LWP = A + [B *(1-C)]. Where A | — |
Countries
United Kingdom
Contacts
Public ContactRebeca James
Outcome results
None listed