CLINICAL STUDY FOR TREATMENT-RESISTANT DEPRESSION – A new psychedelic drug is being investigated for treatment of depression in Maastricht. Patients can now be enrolled.

 

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A phase 1/2 study in patients with treatment-resistant depression

General information:

This study is being carried out by the Faculty of Psychology and Neuroscience of Maastricht University (Universiteitssingel 40, Maastricht). A commercial sponsor is paying for the costs of this study. The Medical Ethics Committee of the University Hospital Maastricht and Maastricht University (METC azM/UM) has approved this study.

Purpose of the study:

The purpose of this study is to investigate the safety and tolerability as well as effects on symptoms of depression of a psychedelic study drug in patients with depression who have not responded sufficiently to prior therapies (so-called “treatment-resistant depression”).

Background of the study:

The study drug is a naturally occurring psychedelic substance, which can temporarily induce alterations of perception, emotion, and consciousness (so-called “psychedelic effects”). The active substance has been used for decades in recreational or self-exploratory settings, which means that significant safety experience already exists.

Initial clinical data for other psychedelic substances, e.g., psilocybin, suggest a benefit of those substances in the treatment of depression and other mental disorders. Benefits observed in patients with depression included rapid anti-depressive effects and durable responses after a single or few doses of those substances.

The present development program aims to demonstrate that the study drug has an improved therapeutic profile compared with these previously studied psychedelic agents and currently available anti-depressive therapies. The program is so far comprised of a healthy volunteer study (completed) and the present study in patients with treatment-resistant depression (ongoing). Participants in the present study will only be dosed with doses shown to be safe in the completed study in healthy volunteers.

Participation requirements for the study:

Participation in the study is possible when you

  • are between 18 and 64 years old;
  • have a Body Mass Index (BMI) between 18.5 and 35 (calculated bodyweight/length2);
  • have a proficient understanding of the English language or are a Dutch speaker;
  • have been diagnosed with depression;
  • had insufficient effect from at least two different treatments (e.g., antidepressant medication, psychotherapy);
  •  do not have a psychotic disorder, such as schizophrenia, or bipolar disorder.

We are looking for people with depression who previously had insufficient effect from at least two different treatments (e.g., antidepressant medication, psychotherapy).

There are additional requirements for study participation, which can be explained to you by the study coordinator (contact details below).

General study procedures:

Participants will take part in 5 separate study visit days.

On the first visit day (Visit A, approximately 1 to 2 hours), a pre-screening will be performed, either as a remote (phone, video) or as a face to face visit.

On the second visit day (Visit B, up to 4 hours), the patients who passed the pre-screening will undergo a detailed medical and psychiatric screening. If the patient is eligible for participation in the study, the second visit day also includes preparation for the psychedelic drug administration and several baseline assessments.

The third visit day (Visit C, approximately 5 hours) will be the day with the administration of the study drug. The patient will be closely monitored, and assessments of the severity of the depression, other psychiatric symptoms, and subjective drug experience are performed at specific time points.

The fourth visit day (Visit D, up to 2 hours) and the fifth visit day (Visit E, up to 2 hours) are follow-up visits where possible side effects are evaluated, and assessments of the severity of the depression, other psychiatric symptoms and cognitive function are performed.

Psychological support via a clinical psychologist and/or psychiatrist is available to the patients on all visit days. Further, a 24-hour phone number is provided where patients can reach the study team in case of questions, psychological difficulties, or medical problems during the entire course of the study.

Adequate measures will be taken to ensure continued care of the participants by their general practitioner and/or responsible psychiatrist after the study.

Compensation for participation:

All participants who pass the pre-screening will be compensated for their time and will also be reimbursed for any reasonable travel cost. Should they live far from Maastricht, two overnight stays at a nearby hotel (from the day before the administration day to the day after the administration day) will be organized and paid for.

Study subject insurance:

Adequate insurance exists for everyone participating in this study.

 

Core study team: Principal investigator Prof. dr. J.G. Ramaekers

 

Department of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience

Maastricht University

Lead study psychiatrist Prof. dr. Therese van Amelsvoort

 

School for Mental Health and Neuroscience

Maastricht University

Study coordinator Johannes Reckweg

 

Department of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience

Maastricht University

fpn-epuonderzoek113@maastrichtuniversity.nl

+31 43 3881530

For more information contact research coordinator Johannes Reckweg:

fpn-epuonderzoek113@maastrichtuniversity.nl

(+31) 043-3881530

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