Clinical trial NCT06793397: A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder
Official title: An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Major Depressive Disorder (MDD)
Keywords: MDD
Psilocybin
Psychedelic
Depression
Major Depressive Disorder
CYB003
CYB003-001
CYB003-002
psilocin-7438
Lead sponsor: Cybin IRL Limited
Sponsor class: INDUSTRY
Collaborators: name: Worldwide Clinical Trials
First posted: 2025-01-27
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.


Eligibility criteria: Inclusion Criteria:

* Participants must meet all the following criteria to be included in the trial:
* Age18 to 85 years.
* Participant has a diagnosis of MDD.
* Moderate to severe depression at Screening.
* Participants have been on a stable dose of antidepressant medication at an adequate dose in the last 4 weeks prior to Screening.
* Participant has a body mass index (BMI) of 40 kg/m2 or less (BMI ≤40 kg/m2), inclusive, at Screening.
* Participants with well controlled hypertension.
* Participant is able to refrain from smoking during the dosing session.
* Participants must use a condom plus spermicide during the trial and for 12 weeks afterwards.

Participants of childbearing potential must agree to use a highly effective method of and a negative pregnancy test at Screening and Day -1 prior to dosing.

* Participants of non-childbearing potential who are or were capable of producing eggs (ova) must have been postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
* Participants have provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.

Exclusion Criteria

* Participants with any of the following characteristics/conditions will be excluded from trial participation:
* Current or previously diagnosed schizophrenia spectrum or other psychotic disorders.
* Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives).
* Significant suicide risk within 12 months of Screening.
* Current or previous diagnosis of treatment-resistant MDD.
* Has had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of MDD in the last 6 months.
* Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressants, mirtazapine, trazodone, moclobemide, buspirone, or an antipsychotic or mood stabilizer.
* Clinically relevant history of abnormal physical health interfering with the trial (including but not limited to, neurological, cardiovascular, respiratory, gastrointestinal \[including dyspepsia or gastroesophageal reflux disease\], hepatic, or renal disorder).
* Has hypothyroidism or hyperthyroidism, unless controlled on appropriate medication.
* Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically relevant abnormal results for heart rate.
* Participants have a presence or relevant history of organic brain disorders.
* Participant is taking or has taken OTC doses of 5 hydroxytryptophan or St John's Wort within prior to trial medication administration.
* Strenuous exercise prior to each clinic visit.
* Donation of blood or plasma within 4 weeks prior to first dosing and until 4 weeks after final dosing.
* Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 12 weeks after final dosing.
* Participants of childbearing potential who are pregnant, breastfeeding, planning to conceive or unwilling to abstain from egg (ova) donation between first dosing and 12 weeks after final dosing.
* History of serotonin syndrome.
* Unwilling to consent to audio and video recording of psychological support and dosing sessions.

Primary outcomes:
measure: Montgomery-Asberg Depression Scale (MADRS)
timeFrame: Screening Day-45, Baseline, Day -1, Day 21, Day 42, Day 63 and Day 84/End of Trial.
Secondary outcomes:
measure: The Beck Depression Inventory - Second Edition (BDI-II)
timeFrame: Day -1, Day 21, Day 42 and Day 84/End of Trial.
measure: The Clinical Global Impression Scale (CGI-S)
timeFrame: Screening Day-45, Baseline Day -1, Day 42, Day 84/End of Trial.
measure: The Generalized Anxiety Disorder 7-Item Scale (GAD-7)
timeFrame: Baseline Day -1, Day 21, Day 42, Day 63 and Day 84/End of Trial.
measure: The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
timeFrame: Day -1, Day 21, Day 42 and Day 84/End of Trial.
Other outcomes:
Locations:
Study officials:
affiliation: Cybin IRL Limited
name: Felix Mazer
role: STUDY_DIRECTOR
References: