RecruitingPhase 3interventionalRules rewrite

Phase 3: testing CYB003 for Major Depressive Disorder (MDD)

This study wants to determine the how well it works, whether it is safe and how hard side effects are to live with of CYB003 compared to matching dummy treatment (placebo) as added on top of your current treatment treatment in patients with major depression. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/

Official registry: https://clinicaltrials.gov/study/NCT06793397 · Cybin IRL Limited · enrollment listed as 330

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are CYB003, or Psychological Support. The registry lists allocation as randomized. This study wants to determine the how well it works, whether it is safe and how hard side effects are to live with of CYB003 compared to matching dummy treatment (placebo) as added on top of your current treatment treatment in patients with major depression.

They plan to enroll about 330 people at 79 sites. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

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

Interventions: CYB003, Psychological Support

Primary outcome (registry wording): Montgomery-Asberg Depression Scale (MADRS)

Who it is for (from inclusion criteria)

Ages 18 Years to 85 Years
Participants must meet all the following criteria to be included in the trial:
Participant has a diagnosis of major depression (single or recurrent episode as defined by DSM-5 TR \[if single episode, duration of ≥4 weeks and ≤24 months\] and established as per evaluation by the Investigator. The first major depression episode must have occurred prior to age 60
Moderate to severe depression at Screening and Baseline, independently confirmed
Participants have been on a stable dose of antidepressant medication (label specified) at an adequate dose in the last 4 weeks prior to Screening and has had an inadequate response (less than 50% improvement), as judged by the Investigator
Participant has a body mass index (body-mass index (BMI)) of 40 kg/m2 or less (body-mass index (BMI) ≤40 kg/m2), inclusive, at Screening
Participant is able to refrain from nicotine use during the dosing session (up to 8 hours)
Participants capable of producing sperm must use a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication, if their partner is a person of childbearing potential

Who the registry excludes

Participants with any of the following characteristics/conditions will be excluded from trial participation:
Participants with a medical diagnosis of attention deficit hyperactivity disorder (ADHD) will be excluded if currently taking medication for ADHD
Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives)
Current or previous diagnosis of treatment-resistant major depression, defined as failure to respond to 2 or more antidepressant treatments of 2 different classes given at an adequate dose (label specified) for an adequate duration as judged by the Investigator and clinical interview
Has had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of major depression in the last 6 months
Participant report of (or if available in medical record) treatment with ketamine or S-ketamine use within 6 months prior to Screening
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)

Public study contact (from the registry)

Clinical Development

877-361-4003

clinicaltrialsinfo@cybin.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

79 listed

UAB Psychiatry and Behavioral Neurology — Birmingham, Alabama (recruiting)
Lighthouse Psychiatry — Gilbert, Arizona (recruiting)
Pillar Clinical Research - Little Rock — Little Rock, Arkansas (withdrawn)
Behavioral Research Specialists, LLC — Glendale, California (recruiting)
Sun Valley Research Center — Imperial, California (withdrawn)
CalNeuro Research Group — Los Angeles, California (recruiting)
Lipov Medical Group — Los Angeles, California (recruiting)
ATP Clinical Research — Orange, California (recruiting)
NRC Research Institute — Orange, California (recruiting)
Inland Psychiatric Medical Group Inc (IPMG Research) — San Juan Capistrano, California (not_yet_recruiting)
Psychedelic Science Institute — Santa Monica, California (recruiting)
Stanford University — Stanford, California (withdrawn)

+ 36 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06793397 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06793397?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06793397?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary