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

Phase 2

Completed

• Conditions: Treatment Resistant Depression
• Interventions: Drug: Psilocybin

• Registration Number: NCT04739865
• Lead Sponsor: COMPASS Pathways

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2020-08-10
• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-05
• Primary Completion: 2021-10-14
• Study Completion: 2021-10-14
• Results First Submitted: 2023-06-15
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-08
• Last Update Submitted: 2023-11-08
• Results First Posted: 2023-11-09
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
25 mg COMP360 Psilocybin	Psilocybin	25 mg COMP360 Psilocybin

Primary Outcome Measures

Name	Time	Method
Improvement in Depressive Symptoms	3 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Response	3 weeks	The proportion of participants with a response (defined as a ≥ 50% improvement in Montgomery-Asberg Depression Rating Scale \[MADRS\] total score from Baseline) at Week 3 post psilocybin administration.; The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome.
Incidence of Remission	3 weeks	The proportion of participants with remission (defined as Montgomery-Asberg Depression Rating Scale \[MADRS\] total score ≤ 10) at Week 3 post psilocybin administration The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome.
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.

Trial Locations

Locations (2)

Sheaf House, Tallaght Hospital; 🇮🇪 Dublin, Ireland

Kadima Neuropsychiatry Institute; 🇺🇸 La Jolla, California, United States