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

Sponsor
COMPASS Pathways (Industry)
Overall Status
Completed
CT.gov ID
NCT04739865
Collaborator
(none)
19
2
1
12.9
9.5
0.7

Study Details

Study Description

Brief Summary

A recent open label study of the effects of psilocybin in participants with treatment-resistant depression (TRD) showed rapid significant decrease of depressive symptoms after treatment with psilocybin coupled with psychological support. Over 40% of participants sustained response at 3 months. In this study, the aim is to explore effectiveness of 25 mg of psilocybin as an adjunctive therapy in participants with TRD.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open labelOpen label
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression
Actual Study Start Date :
Sep 15, 2020
Actual Primary Completion Date :
Oct 14, 2021
Actual Study Completion Date :
Oct 14, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Psilocybin

25mg Psilocybin

Drug: Psilocybin
Open label
Other Names:
  • COMP360
  • Outcome Measures

    Primary Outcome Measures

    1. Improvement in depressive symptoms [3 weeks]

      Change in Montgomery-Asberg Depression Rating Scale total score from Baseline to 3 weeks post psilocybin administration. The minimum and maximum values are 0 and 6 and a higher score means a worse outcome.

    Secondary Outcome Measures

    1. Incidence of response [3 weeks]

      The proportion of participants with a response (defined as a ≥ 50% improvement in Montgomery-Asberg Depression Rating Scale total score from Baseline) at Week 3 post psilocybin administration. The minimum and maximum values are 0 and 60 and a higher score means a worse outcome.

    2. Incidence of remission [3 weeks]

      The proportion of participants with remission (defined as Montgomery-Asberg Depression Rating Scale total score ≤ 10) at Week 3 post psilocybin administration The minimum and maximum values are 0 and 60 and a higher score means a worse outcome.

    3. Improvement in Clinical Global Impression - Severity [3 weeks]

      Changes from Baseline in Clinical Global Impression-Severity score at Week 3 post psilocybin administration. The minimum and maximum values are 1 and 7 and a higher score means a worse outcome. The minimum and maximum values are 0 and 7, respectively and a higher scores means a worse outcome.

    4. Adverse Events [3 weeks]

      Incidence of Adverse Events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Signed ICF.

    2. 18 years of age or older

    3. At least moderate MDD

    4. Hamilton Depression Rating Scale (17 item) score ≥18

    5. Currently receiving treatment with a selective serotonin reuptake inhibitor

    6. Failure to respond to an adequate dose and duration of 2, 3, or 4 pharmacological treatments

    7. McLean Screening Instrument for Borderline Personality Disorder <7 at Screening (V1).

    8. Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.

    Exclusion Criteria:
    Psychiatric Exclusion Criteria:
    1. 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).

    2. Prior electroconvulsive therapy and/or ketamine for current episode.

    3. Ongoing use of an antidepressant medication, including augmentation or combination therapies, other than a single SSRI

    4. 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.

    5. Current (within the last year) alcohol or substance use disorder as informed by DSM 5 (diagnosed by MINI 7.0.2) at Screening (V1).

    6. Significant suicide risk as defined C-SSRS within the past year

    7. Depression secondary to other severe medical conditions according to clinicians' judgement.

    8. 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.

    General Medical Exclusion Criteria:
    1. Women who are pregnant, nursing or planning a pregnancy.

    2. Cardiovascular conditions

    3. Uncontrolled or insulin dependent diabetes.

    4. Seizure disorder.

    5. Positive urine drug screen for illicit drugs or drugs of abuse

    6. Current enrolment in any investigational drug or device study or participation in such within 30 days prior to Screening (V1).

    7. Current enrolment in another clinical study of an investigational medical or participation in such within 30 days of Screening (V1).

    8. Abnormal and clinically significant results on the physical examination, vital signs, ECG or laboratory tests at Screening (V1).

    9. Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kadima Neuropsychiatry Institute La Jolla California United States 92037
    2 Sheaf House, Tallaght Hospital Dublin Ireland

    Sponsors and Collaborators

    • COMPASS Pathways

    Investigators

    • Principal Investigator: Guy Goodwin, University of Oxford

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    COMPASS Pathways
    ClinicalTrials.gov Identifier:
    NCT04739865
    Other Study ID Numbers:
    • COMP003
    First Posted:
    Feb 5, 2021
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2022