A dose-finding and proof-of-concept study of the efficacy and safety of MSP-1014.OX in patients with major depressive disorder

Phase 2

Active, not recruiting

• Conditions: Major depressive disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN31103960
• Lead Sponsor: Clerkenwell Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-28
• Last Update Posted: 3 October 2023
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Aged 18 years and above
2. Male or female
3. DSM-5 defined MDD with partial response SSRI monotherapy (HAM-D score >17) or no response
4. Able to communicate well in English and follow study procedures
5. Any history of suicide attempts/suicidal ideation; the subject scores 'yes' on item 4 or 5 of the Suicidal Ideation section of the Columbia Suicidality Scale Scoring if this ideation occurred in the past 12 months, or 'yes' on any item of the Suicidal Behaviour Section, and the opinion of the investigator
6. Medically suitable as determined by screening including a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and blood tests
7. Currently taking a first course of SSRI antidepressant treatment for at least 8 weeks

Exclusion Criteria

1. Treatment with any other antidepressant medication other than the currently prescribed SSRI antidepressant
2. Current or past diagnosis of schizophrenia, psychotic disorder, bipolar disorder I and II, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, or judged to be incompatible with establishment of rapport or safe exposure to psilocybin, as assessed through medical history and the Mini International Neuropsychiatric Inventory (MINI)
3. Family history of schizophrenia, schizoaffective disorder, or bipolar affective disorder
4. Anyone on a research study of an investigational drug or who has been on a clinical trial within 1 month of enrollment
5. Scores from the screener and baseline Columbia Suicide Severity Rating Scale (C-SSRS) that indicate that the participant is of clinically significant risk of suicide. A decision will be formed based on C-SSRS scores and used in combination with other clinically significant data at screening and baseline.
Judged to be of high suicide or self-harm risk following psychological assessment at screening or baseline.
6. Currently receiving psychotherapy other than that which forms far this study
7. Current (<1 year) alcohol or drug abuse identified as moderate or severe during screening in accordance with ICD-11 criteria, through the MINI 7.0.2
8. Any other reason that might compromise safe exposure to psilocin and the development of a therapeutic relationship necessary for psychological support
9. Previous use of psychedelics in lifetime

Medical Exclusion Criteria:
1. Females who are pregnant, breastfeeding or of childbearing potential who are unwilling or unable to use an effective form of contraception (or abstinence) for the duration of the study. Women will be required to conduct a serum pregnancy test at the in-person screening visit and a urine test prior to dosing at the drug-assisted therapy session. Male participants who do not agree to use contraception for 2 weeks following each dosing session to mitigate the risk of pregnancy will also be excluded.
2. A diagnosis of epilepsy or at significant risk of seizures based on medical history
3. Cardiovascular conditions including stroke (less than 1 year before providing informed consent [IC]), myocardial infarction (<1 year from IC), uncontrolled hypertension (blood pressure >140/90 mmHg) or clinically significant arrhythmia within 1 year of IC
4. Anyone who, at screening, has clinically significant findings on physical examination, including vital signs (HR below 60 or above 100 bpm, blood pressure below 90/60 or above 140/90), ECG (ST greater than 450 msec), and positive alcohol breath test
5. An estimated glomerular filtration rate (eGFR) of <45 ml/min/1.73 m²
6. Results falling above 2.5 times the upper reference level on alanine aminotransferase 0-45 IU/L, aspartate aminotransferase 0-50 IU/L, gamma-glutamyl transferase 0-70 IU/L (male), 0-40 IU/L (female)
7. Results falling above 1.5 times the upper reference level on bilirubin 3-20 µmol/L
8. Results falling above 1.0 times the upper reference level on conjugated bilirubin 0-14 µmol/L
9. Results falling above 1.0 times the upper reference level on alkaline phosphatase 90-300 IU/L
10. Any clinically significant renal, pulmonary, gastrointestinal, hepatic, or other illness that could affect the interpretation of results or be a potential health risk for the person if they were to be included in the study
11. Below 16 or above

Study & Design

• Study Type: Interventional
• Study Design: Not specified