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New treatment option for Treatment Resistant Depression
Official title Psilocybin for Hospitalized Patients with Treatment-resistant Depression
ClinicalTrials.gov ID: NCT06378229
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for treatment resistant depression.
Also referred to as PEX010.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- people 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...
- The people are abstinent from alcohol (breathalyzer blood alcohol concentration (BAC) level 0.00) and provide a negative urine drug screen at the...
- The female people provide a negative pregnancy test at the dosing day.
You likely can't join if
- 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...
- 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...
- 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...
- cluster B personality disorder. people will be screened for the presence of those personality traits by using the NEO-FFI-3.
See the full eligibility 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...
- people 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 people 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 people provide a negative pregnancy test at the dosing day.
- The people 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...
- A partner is willing to participate in the study (a cohabiting relationship of at least 1 year).
- 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...
- 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. people 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.
- 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:
- Cardiovascular conditions: recent stroke (\ 140/90 mmHg) or clinically significant arrhythmia within 1 year of signing the ICF.
- Uncontrolled insulin-dependent diabetes mellitus.
- Uncontrolled epilepsy.
- 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...
- 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...
- Pregnant or breast-feeding women.
- Those unable to give informed consent.
- Those enrolled in another trial.
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Oost-Vlaanderen, Belgium
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Oost-Vlaanderen, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.