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Clinical trials for psilocybin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    19 result(s) found for: psilocybin. Displaying page 1 of 1.
    EudraCT Number: 2018-003382-34 Sponsor Protocol Number: NeuroPharm_EPOCH Start Date*: 2019-06-17
    Sponsor Name:NeuroPharm
    Full Title: Prophylactic effects of psilocybin on chronic cluster headache: an open-label clinical trial and neuroimaging study.
    Medical condition: Chronic cluster headache.
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004848 10056941 MRI brain LLT
    21.1 100000004852 10009698 Cluster headaches LLT
    21.1 100000004852 10020397 Horton's headache LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-003984-24 Sponsor Protocol Number: EPIsoDE_01 Start Date*: 2020-11-17
    Sponsor Name:Central Institute of Mental Health
    Full Title: A phase II randomized, double-blind, active placebo-controlled parallel group trial to examine the efficacy and safety of psilocybin in treatment-resistant major depression
    Medical condition: Treatment-Resistant Depressive Episode or Treatment-Resistant Recurrent Depressive Disorder of moderate to severe degree withoutpsychotic features
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-003381-21 Sponsor Protocol Number: RAFAEL Start Date*: 2023-09-11
    Sponsor Name:Psyon, s.r.o.
    Full Title: Regression of atherosclerosis induced by life changing experience with psilocybin
    Medical condition: Ischemic Heart Disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004480-31 Sponsor Protocol Number: PSIKET_001CZE Start Date*: 2020-07-14
    Sponsor Name:Národní ústav duševního zdraví
    Full Title: Psilocybin versus ketamine – fast acting antidepressant strategies in treatment-resistant depression
    Medical condition: The study will include 60 patients with pharmaco-resistant depression (30 male, 30 female, aged 18–65). The basic inclusion criterion is the diagnosis of pharmaco-resistant moderate to severe depre...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003288-36 Sponsor Protocol Number: COMP001 Start Date*: 2018-03-09
    Sponsor Name:COMPASS Pathways, Ltd
    Full Title: The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression (P-TRD)
    Medical condition: Treatment-Resistant Depression (P-TRD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10025454 Major depressive disorder, recurrent episode LLT
    21.1 100000004873 10025463 Major depressive disorder, single episode LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) CZ (Completed) DE (Completed) PT (Completed) NL (Completed) IE (Completed) DK (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-004579-37 Sponsor Protocol Number: MZ12-PCP-PalenicekTomas-A Start Date*: 2014-06-18
    Sponsor Name:National Institute of Mental Health
    Full Title: Animal and human serotonergic model of schizophrenia: validity evaluated by qEEG and fMRI
    Medical condition: Inclusion criteria: a) Men and women at age between 28 and 65 years b) healthy volunteers with negative psychiatric history (severe mental illnesses that meet the criteria of ICD 10 F0.X - F99.X) ...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-002577-22 Sponsor Protocol Number: COMP003 Start Date*: Information not available in EudraCT
    Sponsor Name:COMPASS Pathfinder, Limited
    Full Title: The safety and efficacy of psilocybin as an adjunctive therapy in participants with treatment-resistant depression
    Medical condition: treatment resistant depression
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10025454 Major depressive disorder, recurrent episode LLT
    21.1 100000004873 10025463 Major depressive disorder, single episode LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005037-32 Sponsor Protocol Number: PSIKET_002CZE Start Date*: 2021-09-22
    Sponsor Name:Národní ústav duševního zdraví
    Full Title: Psilocybin - a strategy of rapid antidepressant response in depression comorbid with cancer, a randomized double-blind study with the possibility of entering open extension.
    Medical condition: Depressive disorder comorbid with cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10012378 Depression PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-002909-10 Sponsor Protocol Number: P137 Start Date*: 2022-10-24
    Sponsor Name:Maastricht University
    Full Title: THE IMPACT OF PSILOCYBIN ON PAIN IN FIBROMYALGIA PATIENTS AND HEALTHY VOLUNTEERS: A MULTICENTER TRIAL
    Medical condition: Fibromyalgia
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000041-40 Sponsor Protocol Number: P131 Start Date*: 2022-02-22
    Sponsor Name:Maastricht University
    Full Title: A study to investigate the effects of repeated low doses of psilocybin and ketamine on cognitive and emotional dysfunctions in Parkinson’s disease and to understand its mechanism of action
    Medical condition: Parkinson's disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003196-35 Sponsor Protocol Number: 13HH0762 Start Date*: 2015-01-07
    Sponsor Name:Imperial College London
    Full Title: Assessing the subjective intensity of oral psilocybin in patients with treatment-resistant depression: A Pilot Study
    Medical condition: Major depressive disorder
    Disease: Version SOC Term Classification Code Term Level
    18.0 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-002790-94 Sponsor Protocol Number: 200828 Start Date*: 2020-09-16
    Sponsor Name:SLSO
    Full Title: The Effect of Psilocybin on MDD Symptom Severity and Synaptic Density – A Single Dose Randomized, Double Blind, Placebo-Controlled Phase 2 Positron Emission Tomography Study
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10025462 Major depressive disorder, recurrent episode, unspecified degree LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-003573-97 Sponsor Protocol Number: PSIDER Start Date*: 2020-08-27
    Sponsor Name:King's College London [...]
    1. King's College London
    2. South London & Maudsley NHS Foundation Trust
    Full Title: A randomised, placebo controlled trial of psilocybin in treatment resistant depression: A feasibility study
    Medical condition: Major depressive disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-000219-18 Sponsor Protocol Number: PsiloRCT001 Start Date*: 2018-04-09
    Sponsor Name:Imperial College London
    Full Title: Psilocybin vs. escitalopram for major depressive disorder: comparative mechanisms
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10057840 Major depression PT
    20.0 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-001348-25 Sponsor Protocol Number: COMP004 Start Date*: 2020-07-08
    Sponsor Name:COMPASS Pathways, Ltd
    Full Title: A multicentre study to assess safety and efficacy of psilocybin in patients with treatment-resistant depression following completion of COMP 001 and COMP 003 trials (P-TRD LTFU)
    Medical condition: Treatment-Resistant Depression (P-TRD)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10025463 Major depressive disorder, single episode LLT
    21.1 100000004873 10025454 Major depressive disorder, recurrent episode LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) CZ (Completed) DK (Completed) NL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-006233-19 Sponsor Protocol Number: COMP401 Start Date*: 2023-01-20
    Sponsor Name:COMPASS Pathfinder Limited
    Full Title: Efficacy and safety of COMP360 psilocybin therapy in anorexia nervosa: a proof-of-concept study
    Medical condition: Anorexia Nervosa (AN)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-006200-33 Sponsor Protocol Number: CLA-PSY-201 Start Date*: 2022-09-22
    Sponsor Name:Clairvoyant Therapeutics Inc.
    Full Title: A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults with A...
    Medical condition: Alcohol use disorder (AUD)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10037175 - Psychiatric disorders 10080021 Alcohol use disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004054-28 Sponsor Protocol Number: Panorexia Start Date*: 2020-06-23
    Sponsor Name:Imperial College London
    Full Title: Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study
    Medical condition: Anorexia Nervosa
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10002646 Anorexia LLT
    20.0 10037175 - Psychiatric disorders 10002649 Anorexia nervosa PT
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2020-000829-55 Sponsor Protocol Number: PSILO4ALCO Start Date*: 2020-12-16
    Sponsor Name:Psychiatric Centre Copenhagen
    Full Title: Can a one-off administration of psilocybin reduce alcohol intake in patients with alcohol use disorder? A randomized, double-blinded, placebo-controlled clinical trial.
    Medical condition: Alcohol Use Disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10001594 Alcohol dependence syndrome LLT
    21.1 100000004873 10001590 Alcohol addiction LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Ongoing)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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