Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Engrail Therapeutics INC
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female at birth, inclusive of any gender identity, aged 18 to 65 years, inclusive, at Screening
Diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by a Mini-International Neuropsychiatric Interview (MINI) version 7.0.2
Experiencing clinically significant generalized anxiety in need of treatment as measured by Hamilton Anxiety Rating Scale (HAM-A) Screening and Day 1 scores ≥22 and at least moderately severe score symptoms of anxious mood and tension as measured by HAM-A items 1 and 2, respectively, with score each ≥2 at Screening and Day 1
You may not be if
Clinically predominant psychiatric diagnosis other than GAD as confirmed by the MINI
Any past/lifetime/current diagnosis of a neurocognitive disorder, or psychotic disorder, or any current diagnosis of posttraumatic stress disorder, obsessive compulsive disorder or bipolar disorder confirmed by independent adjudication
Reports moderately severe to severe symptoms of depression
Ingested psychotropic medication within 5 half-lives or 21 days (whichever is longer) prior to Day 1, including THC and CBD, and unwillingness to refrain from their use for the entire duration of the trial
Recent suicidal ideation or behavior
Current or recent moderate to severe substance use disorder as assessed by the MINI
Clinically significant abnormal findings in safety assessments
Has significant progressive disorders or unstable medical conditions
Unable to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, is unsuitable for the study
Clareo Health | ENCALM: A Study of ENX-102 as a Monotherapy Treatment in Patients With Generalized Anxiety Disorder
