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

• ClinicalTrials.gov Identifier: NCT04739865
• Recruitment Status: Completed
• First Posted: February 5, 2021
• Last Update Posted: January 26, 2022
• Sponsor: COMPASS Pathways
• Information provided by (Responsible Party): COMPASS Pathways

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
Treatment Resistant Depression	Drug: Psilocybin	Phase 2

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Guy Goodwin; University of Oxford

More Information

• Responsible Party: COMPASS Pathways
• ClinicalTrials.gov Identifier: NCT04739865
• Other Study ID Numbers: COMP003
• First Posted: February 5, 2021
• Last Update Posted: January 26, 2022
• Last Verified: September 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant; Behavioral Symptoms; Mood Disorders; Mental Disorders; Psilocybin; Hallucinogens; Physiological Effects of Drugs; Psychotropic Drugs