Clinical TrialMajor Depressive Disorder (MDD)PsilocybinPsilocybinPlaceboRecruiting

A Phase 3 Trial to Assess CYB003 in Major Depressive Disorder (EMBRACE)

Phase III, quadruple-blind, randomised, placebo-controlled trial (n=330) of CYB003 (8 mg and 16 mg; two dosing sessions ~3 weeks apart) as adjunctive treatment for major depressive disorder.

Target Enrollment
330 participants
Study Type
Phase III interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, parallel-group, quadruple-masked Phase III study evaluating two dose levels of CYB003 versus matching placebo as adjunctive therapy in adults with major depressive disorder on a stable antidepressant regimen.

Participants receive two medicine sessions approximately three weeks apart (8 mg or 16 mg CYB003 or placebo) with manualized psychological support provided throughout; primary outcomes assess efficacy, safety and tolerability.

Key safety exclusions include psychotic disorders, first-degree family history of schizophrenia/schizoaffective disorder/bipolar I, significant suicide risk within 12 months, and medications or conditions that increase serotonin syndrome risk.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

CYB003 8 mg

experimental

CYB003 8 mg in 2 dosing sessions approximately three weeks apart; adjunctive to stable antidepressant; manualized psychological support provided.

Interventions

  • Psilocybin8 mg
    via Oral• two sessions• 2 doses total

    Deuterated psilocin analogue; given adjunctive to current antidepressant.

  • Compound

    Manualized psychological support throughout study (behavioural intervention).

CYB003 16 mg

experimental

CYB003 16 mg in 2 dosing sessions approximately three weeks apart; adjunctive to stable antidepressant; manualized psychological support provided.

Interventions

  • Psilocybin16 mg
    via Oral• two sessions• 2 doses total

    Deuterated psilocin analogue; given adjunctive to current antidepressant.

  • Compound

    Manualized psychological support throughout study (behavioural intervention).

Placebo

placebo

Matching placebo in 2 dosing sessions approximately three weeks apart; manualized psychological support provided. Non-responders eligible for extension with CYB003.

Interventions

  • Placebo
    via Oral• two sessions

    Matching placebo.

  • Compound

    Manualized psychological support throughout study (behavioural intervention).

Participants

Ages
18 – 85
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Participants must meet all the following criteria to be included in the trial:
  • Age18 to 85 years.
  • Participant has a diagnosis of MDD.
  • Moderate to severe depression at Screening.
  • Participants have been on a stable dose of antidepressant medication at an adequate dose in the last 4 weeks prior to Screening.
  • Participant has a body mass index (BMI) of 40 kg/m2 or less (BMI ≤40 kg/m2), inclusive, at Screening.
  • Participants with well controlled hypertension.
  • Participant is able to refrain from smoking during the dosing session.
  • Participants must use a condom plus spermicide during the trial and for 12 weeks afterwards.
  • Participants of childbearing potential must agree to use a highly effective method of and a negative pregnancy test at Screening and Day -1 prior to dosing.
  • Participants of non-childbearing potential who are or were capable of producing eggs (ova) must have been postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
  • Participants have provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.

Exclusion Criteria

  • Exclusion Criteria
  • Participants with any of the following characteristics/conditions will be excluded from trial participation:
  • Current or previously diagnosed schizophrenia spectrum or other psychotic disorders.
  • Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives).
  • Significant suicide risk within 12 months of Screening.
  • Current or previous diagnosis of treatment-resistant MDD.
  • Has had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of MDD in the last 6 months.
  • Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressants, mirtazapine, trazodone, moclobemide, buspirone, or an antipsychotic or mood stabilizer.
  • Clinically relevant history of abnormal physical health interfering with the trial (including but not limited to, neurological, cardiovascular, respiratory, gastrointestinal [including dyspepsia or gastroesophageal reflux disease], hepatic, or renal disorder).
  • Has hypothyroidism or hyperthyroidism, unless controlled on appropriate medication.
  • Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically relevant abnormal results for heart rate.
  • Participants have a presence or relevant history of organic brain disorders.
  • Participant is taking or has taken OTC doses of 5 hydroxytryptophan or St John's Wort within prior to trial medication administration.
  • Strenuous exercise prior to each clinic visit.
  • Donation of blood or plasma within 4 weeks prior to first dosing and until 4 weeks after final dosing.
  • Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 12 weeks after final dosing.
  • Participants of childbearing potential who are pregnant, breastfeeding, planning to conceive or unwilling to abstain from egg (ova) donation between first dosing and 12 weeks after final dosing.
  • History of serotonin syndrome.
  • Unwilling to consent to audio and video recording of psychological support and dosing sessions.

Study Details

Locations

UAB Psychiatry and Behavioral Neurology — Birmingham, Alabama, United States
Lighthouse Psychiatry — Gilbert, Arizona, United States
Pillar Clinical Research - Little Rock — Little Rock, Arkansas, United States
Behavioral Research Specialists, LLC — Glendale, California, United States
Sun Valley Research Center — Imperial, California, United States
CalNeuro Research Group — Los Angeles, California, United States
ATP Clinical Research — Orange, California, United States
NRC Research Institute — Orange, California, United States
Inland Psychiatric Medical Group Inc (IPMG Research) — San Juan Capistrano, California, United States
Psychedelic Science Institute — Santa Monica, California, United States
Stanford University — Stanford, California, United States
Yale School of Medicine - Connecticut Mental Health Center (CMHC) — New Haven, Connecticut, United States
CNS Healthcare — Jacksonville, Florida, United States
Accel Research Sites - Maitland — Maitland, Florida, United States
Aqualane Clinical Research — Naples, Florida, United States
Emory University Dept of Psychiatry and Behavioral Studies — Atlanta, Georgia, United States
Psych Atlanta — Marietta, Georgia, United States
Rush University — Chicago, Illinois, United States
Tandem Clinical Research — Marrero, Louisiana, United States
Johns Hopkins Medicine — Baltimore, Maryland, United States
Institute for Integrative Therapies — Eden Prairie, Minnesota, United States
Bio Behavioral Health — Toms River, New Jersey, United States
New York State Psychiatric Institute — New York, New York, United States
SP Research PLLC — Oklahoma City, Oklahoma, United States
Adams Clinical Philadelphia — Philadelphia, Pennsylvania, United States
Flourish Research Philadelphia — Philadelphia, Pennsylvania, United States
Austin Clinical Trial Partners — Austin, Texas, United States
North Texas Clinical Trials — Fort Worth, Texas, United States
Brain Health Consultants and TMS Center — Houston, Texas, United States
Clinical Trials of Texas, LLC — San Antonio, Texas, United States
Core Clinical Research — Everett, Washington, United States
Seattle Neuropsychiatric Treatment Center — Seattle, Washington, United States
Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
Thompson Brain & Mind Healthcare (TBMH) — Maroochydore, Queensland, Australia
Ramsay Clinic — Melbourne, Victoria, Australia
Neurocentrix Research — Melbourne, Victoria, Australia
Monash University - Notting Hill — Notting Hill, Victoria, Australia
Institute of neuropsychiatric Care (INEP) — Prague, Czechia
Psyon s.r.o. — Prague, Czechia
A-SHINE s.r.o. — Předměstí, Czechia
Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes — Homburg, Saarland, Germany
Charité Universitaetsmedizin Berlin — Berlin, Germany
University Hospital Frankfurt — Frankfurt am Main, Germany
Central Institute of Mental Health — Mannheim, Germany
Eginitio Hospital — Athens, Greece
Attikon University Hospital — Athens, Greece
Papageorgiou General Hospital — Thessaloniki, Greece
Sheaf House - Tallaght Adult Mental Health Service — Dublin, Ireland
La Nua Day Hospital Mental Health Centre — Galway, Ireland
Uniwersytecki Szpital Kliniczny W Białymstoku — Bialystok, Poland
Promente - Centrum Neurologii i Psychogeriatrii w Bydgoszczy — Bydgoszcz, Poland
UCK — Gdansk, Poland
Centrum Badan Klinicznych PI-House Sp. z o.o — Gdansk, Poland
MTZ Clinical Research Powered by Pratia — Warsaw, Poland
Department of Pharmacology and Physiology of CNS — Warsaw, Poland
Cambridge University Hospital NHS — Cambridge, United Kingdom
Clerkenwell Health - Doncaster — Doncaster, United Kingdom
NHS Research Scotland — Edinburgh, United Kingdom
Queen Elizabeth University Hospital — Glasgow, United Kingdom
St Pancras Clinical Research — London, United Kingdom
King's College London — London, United Kingdom
Clerkenwell Health - Welbeck Street — London, United Kingdom
Re:Cognition Health — London, United Kingdom
Clerkenwell Health - Baker Street — London, United Kingdom
Wolfson Unit - Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust — Newcastle upon Tyne, United Kingdom
Ascend Clinical Research — Reading, United Kingdom
Sheffield Health and Social Care NHS Foundation Trust — Sheffield, United Kingdom

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