Psilocybin for hospitalized patients with treatment-resistant depressio

Phase 1

Recruiting

Conditions: treatment-resistant depression
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Therapeutic area: Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]
Therapeutic area: Psychiatry and Psychology [F] - Psychological Phenomena [F02]
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: CTIS2022-501857-35-00

Lead Sponsor: niversitair Ziekenhuis Gent

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Age 18 years or older., Diagnosis of major depressive disorder (single and recurrent episodes) of moderate to severe degree (MADRS score = 20) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), without psychotic features. Included ICD-11 diagnoses are ICD-11: 6A70.1, 6A70.3, 6A71.1, 6A71.3., Subjects have failed to respond to 2 or more antidepressants prescribed at the minimum effective dose for at least 6 weeks. Augmentation with an add-on treatment counts as a second treatment., The subjects are abstinent from alcohol (breathalyzer blood alcohol concentration (BAC) level 0.00) and provide a negative urine drug screen at the dosing day., The female subjects provide a negative pregnancy test at the dosing day., The subjects must be medically stable based on clinical laboratory tests, medical history, vital signs, and 12-lead ECG performed at screening. - In 12-lead ECG, QTcF should be = 450 ms for males or = 470 ms for females and PR-interval < 220 ms at screening., A partner is willing to participate in the study (a cohabiting relationship of at least 1 year)., Inclusion criteria for the subject’s partner: Age 18 years or older.

Exclusion Criteria

Currently comorbid or previously diagnosed DSM-5 diagnosis of a a) major depressive episode with psychotic features. b) psychotic disorder (defined as meeting DSM-5 criteria for any psychotic disorder) on the MINI 7.0, EXCEPT substance/medication induced psychotic disorder where the duration was limited to the acute period of direct intoxication with the substance/medication. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist. c) bipolar disorder (defined as meeting DSM-5 criteria for bipolar type 1 or bipolar type 2) on the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist. d) drug or alcohol dependence syndrome (defined as meeting DSM-5 criteria for any dependence syndrome) on the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist. e) cluster B personality disorder. Subjects will be screened for the presence of those personality traits by using the NEO-FFI-3. f) PTSD (defined as meeting DSM-5 criteria for PTSD) on the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist., Pregnant or breast-feeding women., Those unable to give informed consent., Those enrolled in another trial., Exclusion criteria for the subject’s partner: Those unable to give informed consent., A family history (first-degree relative) of psychosis and/or bipolar disorder., Current active suicidal ideations., Depression secondary to other medical conditions., Medical diagnosis incompatible with psilocybin treatment: a) Cardiovascular conditions: recent stroke (< 1 year from signing of ICF), recent myocardial infarction (< 1 year from signing of ICF), uncontrolled hypertension (blood pressure > 140/90 mmHg) or clinically significant arrhythmia within 1 year of signing the ICF. b) Uncontrolled insulin-dependent diabetes mellitus. c) Uncontrolled epilepsy., Biochemical or electrocardiographic abnormalities determined as clinically significant by a medical doctor., Current intake of Lithium, Disulfiram, MAOIs or inhibitors of UGT1A9 and 1A10., The subject has received any prior treatment with vagal nerve stimulation, or a deep brain stimulation device., Women of childbearing potential not using adequate contraception (methods that can achieve a failure rate of less than 1%: combined hormonal contraception, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).