Tests psilocybin with therapy for hospitalized people with treatment-resistant depression

Trial details

Who runs it

University Hospital, Ghent

Trial code

NCT06378229EU 2022-501857-35-00

Record updated

19 September 2024

Original description

The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression.Read full original descriptionShow less

Psilocybin-assisted Psychotherapy in the Treatment of Patients Hospitalized for Treatment-resistant Depression: an Open-label Feasibility Study with an Experiential and Systemic Focus

The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression.

Inclusion: 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).

Exclusion: Currently comorbid or previously diagnosed DSM-5 diagnosis of a; major depressive episode with psychotic features; 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; 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; 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; cluster B personality disorder. Subjects will be screened for the presence of those personality traits by using the NEO-FFI-3; 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; 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; A family history (first-degree relative) of psychosis and/or bipolar disorder; Depression secondary to other medical conditions; Medical diagnosis incompatible with psilocybin treatment:; 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; Uncontrolled insulin-dependent diabetes mellitus; Uncontrolled epilepsy; 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). A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; Current active suicidal ideations; Biochemical or electrocardiographic abnormalities determined as clinically significant by a medical doctor. PsiHos-D, Version 2.1 dd. 22/02/2024 page 59 of 114 TMP_Protocol AGO CTR_Version 1.0_Effective Date 2022-07-18; Pregnant or breast-feeding women; Those unable to give informed consent; Those enrolled in another trial.

ClinicalTrials.gov NCT06378229 · EU CTIS 2022-501857-35-00