The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression

NCT04739865 | Completed Phase 2 Results FDA Drug

• 1 other identifier: COMP003
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 2

Brief Summary

The Safety and Efficacy of Psilocybin as an Adjunctive Therapy in Participants with Treatment-Resistant Depression

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• Improvement in Depressive Symptoms

  Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to 3 weeks post psilocybin administration. The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome.

  3 weeks

Secondary Outcomes (3)

• Incidence of Response

  3 weeks

• Incidence of Remission

  3 weeks

• Improvement in Clinical Global Impression - Severity

  3 weeks

Study Arms (1)

25 mg COMP360 Psilocybin

EXPERIMENTAL

25 mg COMP360 Psilocybin

Drug: Psilocybin

Interventions

Psilocybin DRUG

Open label

Also known as: COMP360

25 mg COMP360 Psilocybin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed ICF.
• years of age or older
• At least moderate MDD
• Hamilton Depression Rating Scale (17 item) score ≥18
• Currently receiving treatment with a selective serotonin reuptake inhibitor
• Failure to respond to an adequate dose and duration of 2, 3, or 4 pharmacological treatments
• McLean Screening Instrument for Borderline Personality Disorder \<7 at Screening (V1).
• Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.

You may not qualify if:

• Current or past history of schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history, McLean Screening Instrument for Borderline Personality Disorder and a structured clinical interview (version 7.0.2 MINI).
• Prior electroconvulsive therapy and/or ketamine for current episode.
• Ongoing use of an antidepressant medication, including augmentation or combination therapies, other than a single SSRI
• Current psychological therapies that will not remain stable within 21 days of the psilocybin session. Psychological therapies cannot be initiated within 21 days of baseline.
• Current (within the last year) alcohol or substance use disorder as informed by DSM 5 (diagnosed by MINI 7.0.2) at Screening (V1).
• Significant suicide risk as defined C-SSRS within the past year
• Depression secondary to other severe medical conditions according to clinicians' judgement.
• Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin, including exposure to psilocybin within the past year and use of psychedelics, such as ayahuasca, during the current depressive episode.
• Women who are pregnant, nursing or planning a pregnancy.
• Cardiovascular conditions
• Uncontrolled or insulin dependent diabetes.
• Seizure disorder.
• Positive urine drug screen for illicit drugs or drugs of abuse
• Current enrolment in any investigational drug or device study or participation in such within 30 days prior to Screening (V1).
• Current enrolment in another clinical study of an investigational medical or participation in such within 30 days of Screening (V1).

Sponsors & Collaborators

• COMPASS Pathways: lead

Study Sites (2)

Kadima Neuropsychiatry Institute

La Jolla, California, 92037, United States

Location

Sheaf House, Tallaght Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Results Point of Contact

• Title: Chief Medical Officer
• Organization: COMPASS Pathways

info@compasspathways.com

07443136539

Study Officials

• Guy Goodwin

  University of Oxford

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: February 5, 2021
• Study Start: August 10, 2020
• Primary Completion: October 14, 2021
• Study Completion: October 14, 2021
• Last Updated: November 9, 2023
• Results First Posted: November 9, 2023

Record last verified: 2023-11

Locations

US (1); IE (1)