Clinical TrialTreatment-Resistant Depression (TRD)PsilocybinPsilocybinPsilocybinActive not recruiting

Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD (COMP 006)

Phase III, randomised, double-blind, parallel-group study (n=568) comparing two administrations of COMP360 psilocybin at 25 mg, 10 mg and 1 mg in adults with treatment-resistant depression.

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

Detailed Description

International, multi-centre, randomised (2:1:1), parallel-group, double-blind (quadruple-masked) Phase III study assessing efficacy and safety of two administrations of COMP360 (psilocybin) in adults with treatment-resistant depression.

Total planned duration approximately 62 weeks including screening; study includes three parts with follow-up out to 9 weeks (Part A), 26 weeks (Part B) and 52 weeks (Part C) from initial investigational product administration. Psychological support is provided alongside dosing.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

COMP360 25 mg

experimental

COMP360 psilocybin 25 mg with psychological support (two administrations).

Interventions

  • Psilocybin25 mg
    via Oral• two administrations• 2 doses total

    COMP360 administered under supportive conditions

COMP360 10 mg

experimental

COMP360 psilocybin 10 mg with psychological support (two administrations).

Interventions

  • Psilocybin10 mg
    via Oral• two administrations• 2 doses total

    COMP360 administered under supportive conditions

COMP360 1 mg

active comparator

COMP360 psilocybin 1 mg active comparator with psychological support (two administrations).

Interventions

  • Psilocybin1 mg
    via Oral• two administrations• 2 doses total

    Low-dose active comparator; COMP360

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Key Inclusion Criteria:
  • 1. Aged ≥18 years at Screening
  • 2. Major depression without psychotic features (single or recurrent episode as informed by DSM-5)
  • 3. If the current major depressive episode is the participant's first lifetime episode of depression, the length of the current episode must be ≥3 months and ≤2 years at Screening
  • 4. MADRS total score ≥20 at Screening and Baseline
  • 5. TRD, defined as failure to respond to an adequate dose and duration of two, three, or four different pharmacological treatments for the current episode as determined through the MGH-ATRQ
  • 6. At Screening, agreement to discontinue all prohibited medications

Exclusion Criteria

  • Key Exclusion Criteria:
  • 1. Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder (unless substance induced or due to a medical condition), antisocial personality disorder
  • 2. Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity
  • 3. Borderline personality disorder as demonstrated by medical history or MINI plus module
  • 4. Ongoing PTSD, OCD, or anorexia nervosa
  • 5. Psychiatric inpatient within the past 12 months prior to Screening
  • 6. Use of ECT, DBS, or VNS during the current depressive episode
  • 7. TMS within the past six months prior to Screening
  • 8. Current enrolment in a psychological therapy programme that will not remain stable for the duration of the study; psychological therapies cannot have been initiated within 30 days prior to Screening
  • 9. Exposure to COMP360 psilocybin therapy prior to Screening

Study Details

Locations

Lighthouse Psychiatry Scottsdale — Gilbert, Arizona, United States
Clinical Innovations, Inc. — Bellflower, California, United States
M3 Wake Research — Encino, California, United States
The Regents of the University of California - San Diego — La Jolla, California, United States
Kadima Neuropsychiatry Institute — La Jolla, California, United States
CalNeuro Research Group, Inc — Los Angeles, California, United States
Catalina Research Institute, LLC — Montclair, California, United States
Piedmont Hospital Neuroscience Centre — Oakland, California, United States
ATP Clinical Research, Inc. — Orange, California, United States
CITrials — Riverside, California, United States
Lumos Clinical Research Center — San Jose, California, United States
Syrentis Clinical Research — Santa Ana, California, United States
Stanford University — Stanford, California, United States
ASCLEPES Research Centers — Thousand Oaks, California, United States
Pacific Clinical Research Management Group, LLC — Upland, California, United States
Innovative Clinical Research, Inc. — Lauderhill, Florida, United States
Central Miami Medical Institute, LLC — Miami, Florida, United States
Behavioral Clinical Research, Inc. — Miami Lakes, Florida, United States
Health Synergy Clinical Research — Okeechobee, Florida, United States
Clinical Neurosciecne Solutions, Inc. dba CNS Healthcare — Orlando, Florida, United States
APG Research, LLC- Advanced Psychiatric Group — Orlando, Florida, United States
University South Florida — Tampa, Florida, United States
Stedman Clinical Trials — Tampa, Florida, United States
Health Synergy Clinical Research, LLC — West Palm Beach, Florida, United States
Atlanta Center for Medical Research — Atlanta, Georgia, United States
iResearch Atlanta — Decatur, Georgia, United States
Rush University Medical Center — Chicago, Illinois, United States
Uptown Research Institute, LLC — Chicago, Illinois, United States
Psychiatric Medicine Associates — Skokie, Illinois, United States
Harvard Medical School - McLean Hospital — Belmont, Massachusetts, United States
Adams Clinical - Boston (Copley Clinical) — Boston, Massachusetts, United States
University of Massachusetts Medical School — North Worcester, Massachusetts, United States
Adams Clinical - Boston — Watertown, Massachusetts, United States
Michigan Clinical Research Institute PC — Ann Arbor, Michigan, United States
University Of Michigan Comprehensive Depression Center — Ann Arbor, Michigan, United States
Institute for Integrative Therapies — Eden Prairie, Minnesota, United States
St. Charles Psychiatric Associates - Midwest Research Group — Saint Charles, Missouri, United States
Alivation Research, LLC. — Lincoln, Nebraska, United States
Hassman Research Institute — Berlin, New Jersey, United States
Princeton Medical Institute — Princeton, New Jersey, United States
Bio Behavioral Health — Toms River, New Jersey, United States
Dent Neurosciences Research Center, Inc. — Amherst, New York, United States
Fieve Clinical Research, Inc — New York, New York, United States
Spectrum Neuroscience and Treatment Institute — New York, New York, United States
Adams Clinical - New York — New York, New York, United States
New York State Psychiatric Institute — New York, New York, United States
Richmond Behavioral Associates — Staten Island, New York, United States
Adams Clinical - New York — The Bronx, New York, United States
University of Cincinnati, Department of Psychiatry & Behavirol Neuroscience — Cincinnati, Ohio, United States
Cleveland Clinic - Lutheran Hospital — Cleveland, Ohio, United States
The Ohio State University — Columbus, Ohio, United States
Suburban Research Associates — Media, Pennsylvania, United States
The University of Texas at Austin - Dell Medical School — Austin, Texas, United States
Houston Clinical Trials, LLC — Bellaire, Texas, United States
Relaro Medical Trials — Dallas, Texas, United States
Center for Depression Research and Clinical Care — Dallas, Texas, United States
North Texas Clinical Trials — Fort Worth, Texas, United States
Brain Health Consultants and TMS Center — Houston, Texas, United States
HCA Healthcare Research Institute - Medical City Green Oaks Hospital — Plano, Texas, United States
Cedar Clinical Research — Draper, Utah, United States
The University of Utah - Huntsman Mental Health Institute — Salt Lake City, Utah, United States
Seattle Neuropsychiatric Treatment Center — Seattle, Washington, United States
Diex Recherche Sherbrooke Inc. — Québec, B.C., Canada
Medical Arts Health Research Centre, Kamloops — Kamloops, British Columbia, Canada
Okanagan Clinical Trials — Kelowna, British Columbia, Canada
Medical Arts Research Group - Penticton — Penticton, British Columbia, Canada
Chatham-Kent Clnical Trials Centre — Chatham, Ontario, Canada
St. Michael's Hospital — Toronto, Ontario, Canada
Centre for Addiction and Mental Health (CAMH) — Toronto, Ontario, Canada
Centre for Neurology Studies — Vancouver, Canada
Medical Arts Research Group — Vancouver, Canada
National Institute of Mental Health — Klecany, Czechia
Neuroterapie KH Sro — Kutná Hora, Czechia
Psychiatric Ambulance — Ostrava, Czechia
A-Shine s.r.o. — Pilsen, Czechia
Psychedelicka klinika, s.r.o. — Prague, Czechia
Institut Neuropsychiatricke Pece — Prague, Czechia
Aalborg Universitetshospital-Psykiatrien Region Nordjylland — Aalborg, Denmark
Centre Hospitalier Universitaire de Nimes (CHU) - Hopital Universitaire Caremeau — Nîmes, France
Universite Paris VI Pierre et Marie Curie - Hopital de La Salpetriere - Centre Emotion - USR 3246 (CNRS UMR 7593) — Paris, France
Centre Hospitalier Sainte Anne - Clinique des Maladies Mentales et de l'Encephale (CMME) — Paris, France
Ghu-Centre Hospitalier Sainte Anne, Centre de Recherche Clinique — Paris, France
Charite-Universitaetsmedizin Berlin — Berlin, Germany
Johann Wolfgang Goethe-Universitaet Frankfurt am Main - Klinik fuer Psychiatrie, Psychosomatik und Psychotherapie — Frankfurt, Germany
ZiP Campus Luebeck — Lübeck, Germany
Tallaght University Hospital — Dublin, Ireland
La Nua Day Hospital Mental Health Centre — Galway, Ireland
University Medical Center Groningen — Groningen, Netherlands
Leids Universitair Medisch Centrum (LUMC) (Leiden University Medical Center) - Leiden Institute for Brain and Cognition (LIBC) — Leiden, Netherlands
Universitair Medisch Centrum Utrecht (UMC Utrecht) — Utrecht, Netherlands
Promente - Ośrodek Badań Klinicznych — Bydgoszcz, Poland
Uniwersyteckle Centrum Kliniczne, Klinika Psychiatrii Doroslych — Gdansk, Poland
Centrum Badan Klinicznych PI-House Sp. z o.o. — Gdansk, Poland
Hospital Clinic de Barcelona — Barcelona, Spain
Parc Sanitari Sant Joan de Deu (Sant Joan de Deu Serveis de Salut Mental) — Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain
FIDMAG Hermanas Hospitalarias — Sant Boi de Llobregat, Spain
Hospital Universitario Río Hortega de Valladolid — Valladolid, Spain
Hospital Provincial de Zamora - Servicio de Psiquiatria — Zamora, Spain
Vuxenpsykiatrimottagningen — Landskrona, Sweden
Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine) — Lund, Sweden
ClinSmart Sweden AB — Solna, Sweden
Hälsoklustret — Stockholm, Sweden
Cornwall Partnership NHS Foundation Trust — Bodmin, Cornwall, United Kingdom
Abraham Cowley Unit - Surrey and Borders Partnership NHS Foundation Trust — Chertsey, United Kingdom
St. Pancras Clinical Research — Chester, United Kingdom
Grounded Research Hub - Rotherham Doncaster & South Humber NHS Foundation Trust — Doncaster, United Kingdom
Clinical Research Facility, Royal Devon and Exeter Hospital — Exeter, United Kingdom
Fulbourn Hospital - Cambridgeshire And Peterborough NHS Foundation Trust — Fulbourn, United Kingdom
St. Pancras Clinical Research — London, United Kingdom
King's College London - Institute of Psychiatry, Psychology — London, United Kingdom
Clerkenwell Health — London, United Kingdom
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust - Wolfson Research Centre — Newcastle, United Kingdom
University Of Nottingham/Nottinghamshire Healthcare Trust, Institute Of Mental Health — Nottingham, United Kingdom
The Warneford Hospital- NIHR Clinical Research Facility — Oxford, United Kingdom
Sheffield Health and Social Care NHS Foundation Trust — Sheffield, United Kingdom

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