Testing EMP-01 for treating social anxiety disorder

A Phase 2a, Exploratory, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability, and Efficacy of EMP-01 in Adult Participants With Social Anxiety Disorder

This study is testing a new oral treatment called EMP-01 to see if it can help adults with social anxiety disorder feel better compared to a placebo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: atai Therapeutics, Inc. (industry)
• Locations: 6 sites (Bridgetown, Cannock, Staffordshire and 5 other locations)
• Trial ID: NCT06693609 on ClinicalTrials.gov

What this trial studies

This Phase 2 exploratory trial aims to evaluate the safety and tolerability of EMP-01, an oral treatment, in adults diagnosed with social anxiety disorder (SAD). Approximately 60 participants will be randomly assigned to receive either EMP-01 or a placebo in a double-blind manner, with two administrations spaced four weeks apart. The study will monitor participants' symptoms over a six-week period to assess any improvements in social anxiety symptoms compared to the placebo group. The primary focus is on safety, while secondary outcomes will explore efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a confirmed diagnosis of social anxiety disorder and specific severity scores.

Not a fit: Patients with social anxiety disorder that is better attributed to another psychiatric or medical condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for individuals suffering from social anxiety disorder.

How similar studies have performed: Other studies have shown promise in exploring treatments for social anxiety disorder, but the specific approach with EMP-01 is novel.

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.

Where this trial is running

Bridgetown, Cannock, Staffordshire and 5 other locations

• MAC Clinical Research - South Staffordshire — Bridgetown, Cannock, Staffordshire, United Kingdom (RECRUITING)
• MAC Clinical Research - Greater Manchester — Manchester, Greater Manchester, United Kingdom (RECRUITING)
• MAC Clinical Research - Lancashire — Blackpool, Lancashire, United Kingdom (RECRUITING)
• MAC Clinical Research - Merseyside — Liverpool, Merseyside, United Kingdom (RECRUITING)
• MAC Clinical Research - South Yorkshire — Tankersley, South Yorkshire, United Kingdom (RECRUITING)
• MAC Clinical Research - Teesside — Thornaby, Stockton-on-Tees, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Kevin Craig, MD

Conditions: Social Anxiety Disorder