Psychedelic Trials

This open-label trial (n=50) will assess the safety and efficacy of psilocybin-assisted psychotherapy in patients with treatment-resistant major depressive disorder (TRD) in an Australian clinical setting. Participants will receive two doses of psilocybin (25mg each) alongside a structured programme of preparatory and integration psychotherapy sessions over approximately 16–18 weeks.

This open-label, interventional trial (n=100) will investigate the effects of ketamine infusion therapy on Australian veterans with treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). Participants will receive six initial intravenous ketamine infusions over two weeks (35–70mg/70kg per session), followed by up to six maintenance infusions every three to six weeks based on individual response.

This Phase IIb randomised, double-blind trial (n=96) will compare the efficacy and safety of 5 mg psilocybin plus psychological support versus 25 mg psilocybin plus psychological support in adults with severe generalised anxiety disorder (GAD). Participants will receive two doses, one month apart, and their symptoms will be assessed over a total study duration of 33 weeks.

This open-label, early Phase I trial (n=10) will investigate the effects of a single intravenous ketamine infusion (35mg/70kg over 40 minutes) on glutamatergic activity and synaptic strength in individuals with treatment-resistant major depressive disorder (MDD).

This open-label Phase III trial (n=31) will assess the feasibility and efficacy of combining intravenous ketamine (35mg/70kg over 45 minutes) with immersive virtual reality (VR) for the treatment of adults with treatment-resistant depression (TRD).

This Phase I interventional trial (n=50) will study the pharmacokinetics (how the drug moves through the body) and pharmacodynamics (the drug’s effects on the body) of ketamine in postpartum women following a caesarean delivery. Participants will receive a ketamine infusion (12.6mg/70kg/hr for 1 hour, followed by 3.5mg/70kg/hr for 11 hours) to assess how the drug is metabolised and its potential role in managing post-surgical pain and postpartum depression.

This triple-blind, placebo-controlled, within-subjects trial (n=50) will investigate whether various psychoactive substances can produce experiences similar to classic psychedelics. Participants may receive psilocybin, ketamine, dextromethorphan (DXM), dimethyltryptamine (DMT), methylenedioxymethamphetamine (MDMA), tetrahydrocannabinol (THC), or a placebo across up to six experimental sessions.

This triple-blind, placebo-controlled trial (n=10) will assess the feasibility of Psilocybin-Assisted Psychotherapy (PAP) in treating severe irritable bowel syndrome (IBS). Participants will receive a single 25 mg oral dose of psilocybin or a 100 mg dose of niacin (a placebo) during a guided psychotherapy session.

This quadruple-blind, placebo-controlled trial (n=36) will investigate the role of stress response in shaping the positive effects of psilocybin (25mg or 1mg) by using metyrapone (750mg) to suppress cortisol production.

This quadruple-blind, randomised, low-dose controlled trial (n=108) will study the safety and effectiveness of psilocybin therapy in reducing depression and psychological distress in palliative patients with chronic obstructive pulmonary disease (COPD), amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), or atypical Parkinsonian disorder (APD). Participants will receive either two escalating doses of psilocybin (15mg followed by 25mg) or two low doses (1mg).

This triple-blind, placebo-controlled trial (n=36) will study the effects of a single 25 mg dose of psilocybin (PEX010) on brain function, cognitive flexibility, and clinical outcomes in individuals receiving medication-assisted treatment (MAT) for opioid use disorder (OUD). Participants will be randomly assigned to receive either 25 mg or 1 mg of psilocybin in a 2:1 ratio.

This randomised, blinded, Phase III trial (n=156) will investigate the effects of MDMA-assisted psychotherapy (70mg/70kg, with a 35mg/70kg supplemental dose; 105mg/70kg in the second session if well tolerated, otherwise 70mg/70kg, with a 35mg/70kg supplemental dose; doses rounded to the nearest 40 mg, max 120 mg initial dose) on social anxiety in young autistic people, compared with psychotherapy assisted by dexamfetamine (20mg, with a 10mg supplemental dose), lorazepam (2mg, with a 3mg dose in the second session), diphenhydramine (50mg, increasing to 75mg), or placebo.

This single-masked, randomised controlled trial (n=60) will evaluate the effectiveness of psilocybin (5-6 g per session, two doses six weeks apart) and psilocybin-assisted cognitive behavioural therapy (CBT) in treating major depressive disorder (MDD).

This triple-blind, placebo-controlled trial (n=40) will assess the effects of nebulized ketamine (105mg/70kg) on depressive symptoms in adult inpatients with moderate to severe depression. An active placebo, midazolam (2.1mg/70kg), will be used for comparison.

This open-label, Phase II trial (n=20) will study the effects of a single intravenous (IV) dose of ketamine (35mg/70kg over 40 minutes) on cognitive flexibility in adolescents and young adults (ages 16–26) who are medically hospitalised for anorexia nervosa or atypical anorexia nervosa.

This triple-blind, randomised, placebo-controlled Phase II trial (n=30) will assess the feasibility, tolerability, and preliminary effectiveness of psilocybin (25mg, single oral dose) for managing chronic neuropathic pain. The control group will receive an active placebo, dextromethorphan (400mg, single oral dose), with both groups receiving psychological support.

This open-label Phase I trial (n=20) will investigate the feasibility, tolerability, and safety of administering psilocybin (10mg safety dose, followed by 25mg treatment dose) in autistic adults with treatment-resistant depression (TRD).

This open-label, Phase I trial (n=12) will investigate the effects of different methods of esketamine administration (28 mg nasal spray vs. 28 mg oral solution) with and without CYP3A4 inhibitors (grapefruit juice or cobicistat) on drug absorption and metabolism.

This randomised, quadruple-blind, placebo-controlled trial (n=24) will assess the safety, tolerability, and pharmacokinetics of multiple doses of MLS101 (psilocybin) in healthy participants.

This open-label, interventional trial (n=96) will investigate the neural circuits underlying negative emotional bias in depressive disorders and their response to esketamine (Spravato).

This double-blind, randomised, placebo-controlled trial (n=120) will investigate the interaction between psilocybin (up to 25 mg, oral) and the context of its administration in healthy volunteers with moderate-to-lower-than-average mental well-being.

This observational study (n=200) will examine how the brain's information processing changes during and after the administration of serotonergic psychedelics, including psilocybin, DMT, and LSD, in individuals with and without mental illness who are receiving these substances through clinical trials at Yale University.

This observational cohort study (n=450) will compare the long-term effectiveness, safety, and patient satisfaction of intravenous (IV) ketamine versus intranasal esketamine (Spravato) for treating major depressive disorder (MDD) that has not responded to at least two antidepressant trials (treatment-resistant depression, TRD).

This open-label, single-arm trial (n=12) will study the effects of a single dose of psilocybin (25mg) on individuals with prolonged grief disorder (PGD).

This Phase III, randomised, open-label trial (n=400) will compare the effectiveness, acceptability, and side effects of intravenous ketamine (60mg per dose) and intranasal esketamine (56–84mg per dose) in patients with treatment-resistant depression (TRD).

This open-label, interventional trial (n=10) will assess the safety and acceptability of up to two sequential doses of 25 mg psilocybin, administered with therapeutic support, in individuals with Bipolar II disorder (BD-II) depression experiencing suicidal ideation.

This open-label, interventional trial (n=120) will investigate the effects of intravenous ketamine (35mg/70kg over 40 minutes, maximum dose 60mg) on brain function, structure, and molecular signatures in patients with major depressive disorder (MDD).

This triple-blind, randomised, placebo-controlled trial (n=60) will study the role of neuroplasticity in the behavioural effects of psilocybin in individuals with mild declines in emotional wellbeing. Participants will receive one of four medication combinations, involving either 25 mg or 1 mg of psilocybin alongside intravenous (IV) midazolam or IV saline.

This Phase IIa, multi-centre, double-blind, randomised, placebo-controlled trial (n=60) will investigate the safety, tolerability, and efficacy of EMP-01 in adults with social anxiety disorder (SAD). Participants will be randomised 1:1 to receive two administrations of either 225 mg EMP-01 or placebo on Day 1 and Day 29, with the primary endpoint assessed at Day 43.

This open-label trial (n=10) will investigate the effects of a single dose of MDMA on social cognition in adults with Borderline Personality Disorder (BPD).