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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Mallika Punukollu
-
mpunukollu@clerkenwellhealth.com


Dr Clare Knight
+44 (0)7825 664 326
clare@clerkenwellhealth.com


Dr Paul Morrison
+44 (0)779 1559 814
pmorrison@clerkenwellhealth.com


Dr Henry Fisher
-
henry@clerkenwellhealth.com


Study Location:

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Be Part of Research - Trial Details - A clinical trial of 5 mg psilocybin plus psychological support vs 25 mg psilocybin plus psychological support in adults with generalised anxiety disorder
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A clinical trial of 5 mg psilocybin plus psychological support vs 25 mg psilocybin plus psychological support in adults with generalised anxiety disorder

Recruiting

Open to: All Genders

Age: Adult

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Medical Conditions

Generalised anxiety disorder

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The aim of this study is to compare the effectiveness and safety of 5 mg psilocybin plus psychological support with 25 mg psilocybin with psychological support in adults with a diagnosis of generalised anxiety disorder (GAD) who may or may not be taking selective serotonin reuptake inhibitors (SSRIs).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

31 Aug 2024 01 Jun 2025

Participants will receive two separate doses of either 5 mg of psilocybin or 25 mg of psilocybin, 1 month apart in combination with psychological support. GAD symptoms are measured at week 8. Participants will take part in a screening period of up to 4 weeks, a treatment period of 7 weeks and a follow-up period of 22 weeks. In total, participants will take part for up to 33 weeks.


Patients aged 18 - 70 years with GAD who are still experiencing moderate to severe symptoms

You can take part if:



You may not be able to take part if:


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 screening12. 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 years13. 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-SSRS14. Judged to be of high suicide or self-harm risk following psychological assessment at screening or baseline15. Judged to be unfit for psilocybin-assisted therapy based on assessments made during psychological support sessions prior to first dosing session16. Current or recent treatment with prohibited medications 17. History of hallucinogen use disorder, or any use in the past 1 year, or >25 lifetime uses18. History of electroconvulsive treatment (ECT) or transcranial magnetic stimulation treatment, ketamine, or vagal nerve stimulation19. 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


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

Consciousness-expanding effects that may occur directly after administration: psilocybin may influence the patient’s feelings (euphoria, joy, but also fear and panic), it may induce altered perception through the senses, a distortion of time and space and it may alter how the patient’s body feels. In some cases, this can be experienced as emotionally challenging and cause short periods of paranoia. Physically, this can manifest as a rapid heart rate, raised blood pressure, or a feeling of tightness, nausea, headache, agitation, dizziness, rapid eye movements and dilated pupils.
Other side effects may occur after administration: It may induce a mild headache. In rare cases, some people report an ongoing disturbance in their vision and unpleasant sensations, emotions or charged memories long after the drug has left the body.
The present trial has implemented various precautions to minimize this risk. This includes dosing based on a dose range that has been shown to be safe in healthy volunteers and patients with common mental disorders. Furthermore, the use of other drugs or medications with known cross-reactions is not permitted.
The trial drug will only be administered in a supervised setting with the presence of a medical doctor and only after extensive medical and psychiatric suitability testing. No fatalities have been observed in other modern clinical studies with consciousness-expanding substances that have implemented similar precautions.
Participants will be provided with a 24-hour contact phone number where they can reach the clinical team in case of questions, psychological difficulties, or medical problems during the course of the trial.
Participants may choose to talk about challenging topics, which could potentially cause transient anxiety and distress. It is possible that memories associated with trauma, grief, or intense emotional disturbance will be re-experienced. This risk of harm is minimised by ensuring that therapists are appropriately qualified and experienced and by providing high-quality training trial-specific training to therapists and the research team. In the unlikely event that the negative effects become too overwhelming or traumatic for the participant, benzodiazepines can be prescribed and used to maintain psychological safety by helping the participant de-escalate the adverse effects.
It is anticipated that some participants might have other vulnerabilities in addition to their symptoms related to their diagnosis of GAD, including risk factors of suicidality. The risk of suicidality could increase during the process of completing questionnaires, discussing sensitive issues, and potentially addressing traumatic memories. The risk of suicide will be minimised by exercising clinical judgement to exclude participants who are considered to be of significant suicidal risk. Also, regular monitoring for changes in participants’ suicidal ideation will be assessed using the Columbia Suicide Severity Rating Scale at every study visit. Trial therapists are trained in safeguarding and responding to suicidality risk, and therefore will provide a high level of care to ensure the safety of participants, and be attentive to identifying changes in participant suicidality risk. Participants will also be provided with a contact card with the relevant research team contacts, availability hours, and contacts to signpost the participant to relevant services in case of an emergency
Some of the clinical trial assessments may cause discomfort. A blood draw may be painful and the patient may get a bruise or tenderness where the needle goes into the skin. Having blood taken may also cause the patient to feel nauseated and/or lightheaded. When performing the ECG the patients may have mild irritation, slight redness, or itching of the skin where the stickers (electrodes) are placed. It may be necessary to shave the area on their chest for the placement of stickers directly on the skin. This risk of harm is minimised by providing high-quality training to the research team.

Dr Paul Morrison
+44 (0)779 1559 814
pmorrison@clerkenwellhealth.com


Dr Henry Fisher
-
henry@clerkenwellhealth.com


Dr Mallika Punukollu
-
mpunukollu@clerkenwellhealth.com


Dr Clare Knight
+44 (0)7825 664 326
clare@clerkenwellhealth.com



The study is sponsored by Incannex Healthcare Limited and funded by Psychennex Pty Ltd.




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Read full details for Trial ID: ISRCTN14487299

Or CPMS 60699

Last updated 21 October 2024

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