We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    COMP003

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04739865
Recruitment Status : Completed
First Posted : February 5, 2021
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
COMPASS Pathways

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
Treatment Resistant Depression Drug: Psilocybin Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open 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 : September 15, 2020
Actual Primary Completion Date : October 14, 2021
Actual Study Completion Date : October 14, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psilocybin
25mg Psilocybin
Drug: Psilocybin
Open label
Other Name: COMP360




Primary Outcome Measures :
  1. Improvement in depressive symptoms [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 weeks ]
    Incidence of Adverse Events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  9. Women who are pregnant, nursing or planning a pregnancy.
  10. Cardiovascular conditions
  11. Uncontrolled or insulin dependent diabetes.
  12. Seizure disorder.
  13. Positive urine drug screen for illicit drugs or drugs of abuse
  14. Current enrolment in any investigational drug or device study or participation in such within 30 days prior to Screening (V1).
  15. Current enrolment in another clinical study of an investigational medical or participation in such within 30 days of Screening (V1).
  16. Abnormal and clinically significant results on the physical examination, vital signs, ECG or laboratory tests at Screening (V1).
  17. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04739865


Locations
Layout table for location information
United States, California
Kadima Neuropsychiatry Institute
La Jolla, California, United States, 92037
Ireland
Sheaf House, Tallaght Hospital
Dublin, Ireland
Sponsors and Collaborators
COMPASS Pathways
Investigators
Layout table for investigator information
Principal Investigator: Guy Goodwin University of Oxford
Layout table for additonal information
Responsible Party: COMPASS Pathways
ClinicalTrials.gov Identifier: NCT04739865    
Other Study ID Numbers: COMP003
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: September 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs