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Psilocybin

Phase 2

Treatment Resistant Depression | Small molecule | Psychiatry |Cognition Therapeutics, Inc.|Last Updated: Jul 27, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05029466Psilocybin for Treatment-Resistant DepressionPHASE2 COMPLETED 30Nov 19, 2021Jul 22, 2023Jul 27, 20231 Canada
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Study Endpoints
Primary Endpoints
Feasibility of the study based on participant retention
Up to 24 weeks

Participant drop-out rates will be calculated to determine the feasibility of psilocybin in adults with treatment-resistant depression.

Feasibility of the study based on suicidal ideation and behaviour scores
Up to 24 weeks

Feasibility will be judged based on change in Columbia Suicide Severity Rating Scale (CSSRS) scores. The CSSRS evaluates suicidal ideation and behaviour. The suicidal ideation score ranges from 0 (no ideation) to 5 (active suicidal ideation with specific plan and intent). Suicidal ideation intensity score ranges from 0 (no ideation) to 25 (most severe). The presence of suicidal behaviour is rated as a binary response; the lethality of actual attempts are rated on a scale of 0 (no or very minor physical damage) to 5 (death) and the potential lethality of actual attempts are rated on a scale of 0 (behaviour not likely to result in injury) to 2 (behaviour likely to result in death despite available medical care).

Feasibility of the study based on adverse events
Up to 24 weeks

Feasibility will be judged based on the percentage of participants experiencing serious adverse events and the percentage of adverse events resolving within 48 hours of each dose administration.

Secondary Endpoints
Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Up to 24 weeks
Montgomery-Åsberg Depression Rating Scale (MADRS) response rate
Up to 24 weeks
Montgomery-Åsberg Depression Rating Scale (MADRS) remission rate
Up to 24 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Immediate treatmentEXPERIMENTALParticipants will commence psilocybin treatment immediately upon study enrollment.
Delayed treatmentEXPERIMENTALParticipants will commence psilocybin treatment two weeks after study enrollment.
Interventions
NameTypeDescription
PsilocybinDRUGParticipants will receive a single dose of psilocybin and be assessed weekly for six weeks and biweekly for 18 weeks. Participants who relapse may receive up to two repeated doses of psilocybin.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Over the age of 18 years and under the age of 65; 2. Diagnosed with major depressive disorder or bipolar II disorder by a healthcare provider; 3. Experiencing a major depressive episode (MDE) without psychotic features as defined and operationalized in the DSM-5, where the du...

Countries:Canada
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