Efficacy, Safety, and Tolerability of Two... — Clinical Trial Details | Blossom
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.
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
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.
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
BMI
-
Psychosis History
-
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