Exploratory Safety and Efficacy of EMP-01 in Social Anxiety Disorder

Launched by ATAI THERAPEUTICS, INC. · Nov 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called EMP-01 for people who have social anxiety disorder (SAD). The main goal is to see if EMP-01 is safe to take and if it helps reduce the symptoms of social anxiety. Adults between the ages of 18 and 65 who have been diagnosed with SAD may be eligible to participate. To qualify, participants need to meet specific criteria, such as having a certain level of anxiety and being in a healthy weight range.

If you join the trial, you will take either EMP-01 or a placebo (a pill that looks like the real medication but has no active ingredients) for a short period. Throughout the study, you will attend visits where doctors will check on your health and how you feel. It's important to know that certain medical and mental health conditions may prevent you from participating, such as severe depression or other serious psychiatric disorders. This trial is currently recruiting participants, and if you are interested, you can talk to your doctor for more details.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Eligibility will be assessed at Screening and will be reconfirmed on Day -1 (Baseline) based on available information, before randomization on the following day (Day 1).
• Participants must meet all of the following criteria to be enrolled in this study:
• • Age
• • 1. Participants must be between 18 and 65 years of age, inclusive, at the time of signing the ICF.
• • Disease Characteristics
• • 2. Has a current diagnosis of SAD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR), which is not better attributable to another psychiatric condition or to a medical condition. The diagnosis will be confirmed by the Mini-International Neuropsychiatric Interview (MINI).
• • 3. Clinician-administered LSAS total score ≥ 70 at Screening and Day -1.
• • 4. Clinician Global Impressions - Severity (CGI-S) score ≥ 4 at Screening and Day-1.
• • Weight
• • 5. Body mass index (BMI) within the range 20-34 kg/m2 (inclusive) at Screening.
• • 6. Able (in the investigator's opinion) to comprehend and be willing to sign an ICF, to abide by the study restrictions, and to attend all study visits.
• Exclusion Criteria:
• Participants who meet any of the following criteria will be excluded from this study:
• • Medical Conditions
• • 1. Has a current or prior DSM-5-TR diagnosis of a schizophrenia spectrum and other psychotic disorder, substance/medication-induced psychotic disorder, bipolar and related disorder, or any disorder with psychotic features (including MDD with psychotic features), as assessed by medical history and a structured clinical interview (MINI).
• • 2. Has a current or prior DSM-5-TR diagnosis of a neurocognitive disorder, intellectual disorder, dissociative disorder, disruptive/impulse-control/conduct disorder, autism spectrum disorder (level 2 or 3), or cluster A and B personality disorder, as assessed by medical history and a structured clinical interview (MINI). Inclusion of individuals with a diagnosis of autism spectrum disorder level 1 may be considered at the discretion of the investigator if the participant no longer meets criteria for the condition and current functioning and/or subthreshold symptoms will not interfere with treatment or compliance in the study.
• • 3. Has a current DMS-5-TR diagnosis of SAD performance only sub-type, PTSD, acute stress disorder, anorexia nervosa, bulimia nervosa, or any other co-morbid psychiatric condition that dominates the clinical presentation and would interfere with experimental treatment.
• • 4. Has a current DMS-5-TR disorder, other than SAD, which is the primary focus of treatment. Note that participants with concurrent GAD are eligible for the study, provided that GAD is not the primary diagnosis. Participants with attention deficit hyperactivity disorder (ADHD) are eligible for the study, provided that they do not require pharmacological treatment for the condition AND if ADHD is not the primary diagnosis.
• • 5. Has severe current depression, as measured by a total score ≥ 16 on the QIDS-SR-16.
• • 6. Has a history of moderate or severe alcohol or cannabis use disorder within 1 year before Screening. Has any severity (including mild) of other substance use disorder (drug) within 1 year before Screening, as confirmed by the MINI.
• • 7. Has had suicidal ideation with some intent to act within 6 months before Screening or a history of suicidal behavior within the past 1 year before Screening.