The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression (P-TRD)
- Conditions
- 10027946treatment resistant depression
- Registration Number
- NL-OMON55858
- Lead Sponsor
- COMPASS Pathfinder, Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 53
Participants meeting all the following inclusion criteria at Screening (V1)
should be considered for admission into the study
1. Signed ICF.
2. 18 years of age or older at Screening (V1).
3. At least moderate MDD (single or recurrent episode as informed by DSM 5; if
single episode, duration of * 3 months and * 2 years) based on medical records,
clinical assessment and documented completion of the version 7.0.2 MINI.
4. HAM D 17 (17 item) score * 18 at Screening (V1) and at Baseline (V2).
5. Failure to respond to an adequate dose and duration of 2, 3, or 4
pharmacological treatment for the current episode as determined through the MGH
ATRQ and using the supplementary advice on additional antidepressants not
included in MGH ATRQ (Appendix III). Augmentation with an add on treatment
counts as a second treatment, provided it is approved for the adjunctive
treatment of MDD in that country.
6. McLean Screening Instrument for Borderline Personality Disorder < 7 at
Screening (V1).
7. Have successfully discontinued all antidepressant medications at least 2
weeks prior to Baseline (V2).
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.
Participants meeting any of the following exclusion criteria at Screening (V1)
will not be enrolled in the study.
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, borderline
personality disorder, or any serious psychiatric comorbidity as assessed by
medical history and a structured clinical interview (version 7.0.2 MINI).
2. Prior electroconvulsive therapy and/or ketamine for current episode.
3. Current cognitive behavioural therapy (CBT) that will not remain stable for
the duration of the study. CBT cannot be initiated within 21 days of baseline.
4. Current (within the last year) alcohol or substance abuse as informed by DSM
5 at Screening (V1).
5. Significant suicide risk as defined by (1) suicidal ideation as endorsed on
items 4 or 5 on the C-SSRS within the past year, at Screening or at Baseline,
or; (2) suicidal behaviors within the past year, or; (3) clinical assessment of
significant suicidal risk during subject interview.
6. Depression secondary to other severe medical conditions.
7. 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:
8. Women who are pregnant, nursing, or planning a pregnancy. Participants who
are sexually active must agree to use a highly effective contraceptive method
throughout their participation in the study. Women of child bearing potential
must have a negative urine pregnancy test at Screening (V1) and Baseline (V2).
9. Cardiovascular conditions: recent stroke (< 1 year from signing of ICF),
recent myocardial infarction (< 1 year from signing of ICF), hypertension
(blood pressure > 140/90 mmHg) or clinically significant arrhythmia within 1
year of signing the ICF.
10. Uncontrolled insulin dependent diabetes.
11. Seizure disorder.
12. Positive urine drug screen for illicit drugs or drugs of abuse at V1 and/or
V2. Any positive urine drug test will be reviewed with participants to
determine the pattern of use and eligibility will be determined at the
investigator*s discretion in conjunction with the medical monitor.
13. Current enrolment in any investigational drug or device study or
participation in such within 30 days of Screening (V1).
14. Current enrolment in an interventional study for depression or
participation in such within 30 days of Screening (V1).
15. Abnormal and clinically significant results on the physical examination,
vital signs, ECG, or laboratory tests at Screening (V1).
16. 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
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the change in MADRS total score from Baseline (Day 1)<br /><br>to 3 weeks post psilocybin.</p><br>
- Secondary Outcome Measures
Name Time Method