Social Anxiety DisorderPhase 2NCT06693609
Exploratory Safety and Efficacy of EMP-01 in Social Anxiety Disorder
A Phase 2 study testing EMP-01 in people with Social Anxiety Disorder, run by atai Therapeutics, Inc. at 7 sites in United Kingdom.
Trial summary
This Phase 2 study (protocol number EMP-01-201) will determine the safety and tolerability of a short-term treatment with an oral dosage form of EMP-01 in adult participants with social anxiety disorder (SAD) and will assess exploratory efficacy of repeated doses of EMP-01 versus placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- EMP-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 8 May 2025to 10 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Participants must be between 18 and 65 years of age, inclusive, at the time of signing the ICF.
- Disease Characteristics
- 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).
Show all 11Show fewer
- Clinician-administered LSAS total score ≥ 70 at Screening and Day -1.
- Clinician Global Impressions - Severity (CGI-S) score ≥ 4 at Screening and Day-1.
- Weight
- Body mass index (BMI) within the range 20-34 kg/m2 (inclusive) at Screening.
- 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.
Who cannot join
- Participants who meet any of the following criteria will be excluded from this study:
- Medical Conditions
- 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).
- 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.
- 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.
- 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.
Show all 9Show fewer
- Has severe current depression, as measured by a total score ≥ 16 on the QIDS-SR-16.
- 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.
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
MAC Clinical Research - Lancashire
Blackpool, Lancashire, FY2 0JH
MAC Clinical Research - South Staffordshire
Bridgetown, Cannock, Staffordshire, S75 3DL
MAC Clinical Research Centre, West Yorkshire
Leeds, LS10 1DU
MAC Clinical Research - Merseyside
Liverpool, Merseyside, L34 1BH
MAC Clinical Research - Greater Manchester
Manchester, Greater Manchester, M13 9NQ
MAC Clinical Research - South Yorkshire
Tankersley, South Yorkshire, S75 3DL
MAC Clinical Research - Teesside
Thornaby, Stockton-on-Tees, TS17 6EW
About this study
Official title: 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 Phase 2 study (protocol number EMP-01-201) will determine the safety and tolerability of a short-term treatment with an oral dosage form of EMP-01 in adult participants with social anxiety disorder (SAD) and will assess exploratory efficacy of repeated doses of EMP-01 versus placebo.
Read the detailed description
This Phase 2, exploratory, multi-center, double-blind, randomized, placebo-controlled trial will enroll approximately 60 adult participants with SAD, randomized 1:1 to receive a total of 2 double-blind administrations of EMP-01 or placebo with a 4-week interval between each administration during the placebo-controlled treatment period. All participants will have their symptoms monitored for 6 weeks until the conclusion of the study. While the primary objective of the study is to assess the safety and tolerability of EMP-01 in participants with SAD, the secondary objective is to estimate any improvement in social anxiety symptoms of participants compared to placebo.
- Conditions
- Social Anxiety Disorder
- Being tested
- EMP-01, EMP-01 Placebo
- Keywords
- Social Anxiety Disorder
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMP-01Drug
EMP-01 capsules
EMP-01 PlaceboDrug
EMP-01 placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| EMP-01 | Experimental | Not described Receives: Drug: EMP-01 |
| EMP-01 Placebo | Placebo comparator | Not described Receives: Drug: EMP-01 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment emergent adverse events, adverse events of special interest and serious adverse events.
Assess the safety and tolerability of EMP-01 compared with placebo (PBO) in participants with SAD.
Measured: Day 1 to EOS [Day 43]
Incidence of clinically significant abnormalities in physical examinations, vital signs, electrocardiogram parameters, and safety laboratory results.
Assess the safety of EMP-01 compared with placebo (PBO) in participants with SAD.
Measured: Day 1 [post-dose] to Day 57
Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Assess the safety of EMP-01 compared with placebo (PBO) in participants with SAD.
Measured: Baseline to Day 57
Secondary outcomes (1)
Liebowitz Social Anxiety Scale (LSAS)
Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS) total score at Day 43 to evaluate the treatment difference in EMP-01 compared with PBO in improving social anxiety symptoms in participants with SAD 6 weeks after initiating treatment.
Measured: Baseline to EOS [Day 43]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start8 May 2025
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- atai Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EmpathBio, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693609
- Sponsor's protocol ID
- EMP-01-201
- Status last verified
- Apr 2025
- First submitted
- 12 Nov 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06693609
- Acronym / sponsor ID
- EMP-01-201
- Conditions
- Social Anxiety Disorder
- Keywords
- Social Anxiety Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- atai Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- EmpathBio, Inc.
- Study start
- 8 May 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2 study (protocol number EMP-01-201) will determine the safety and tolerability of a short-term treatment with an oral dosage form of EMP-01 in adult participants with social anxiety disorder (SAD) and will assess exploratory efficacy of repeated doses of EMP-01 versus placebo.
Detailed description
This Phase 2, exploratory, multi-center, double-blind, randomized, placebo-controlled trial will enroll approximately 60 adult participants with SAD, randomized 1:1 to receive a total of 2 double-blind administrations of EMP-01 or placebo with a 4-week interval between each administration during the placebo-controlled treatment period. All participants will have their symptoms monitored for 6 weeks until the conclusion of the study. While the primary objective of the study is to assess the safety and tolerability of EMP-01 in participants with SAD, the secondary objective is to estimate any improvement in social anxiety symptoms of participants compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| EMP-01 | Experimental | Drug: EMP-01 |
| EMP-01 Placebo | Placebo comparator | Drug: EMP-01 Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
- Age
- Participants must be between 18 and 65 years of age, inclusive, at the time of signing the ICF.
- Disease Characteristics
- 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).
Key exclusion criteria (9 listed)
- Medical Conditions
- 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).
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMP-01EMP-01 capsules | Drug | EMP-01 |
| EMP-01 PlaceboEMP-01 placebo capsules | Drug | EMP-01 Placebo |
Primary outcome
Incidence and severity of treatment emergent adverse events, adverse events of special interest and serious adverse events.
Time frame: Day 1 to EOS [Day 43]
Assess the safety and tolerability of EMP-01 compared with placebo (PBO) in participants with SAD.
Incidence of clinically significant abnormalities in physical examinations, vital signs, electrocardiogram parameters, and safety laboratory results.
Time frame: Day 1 [post-dose] to Day 57
Assess the safety of EMP-01 compared with placebo (PBO) in participants with SAD.
Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Baseline to Day 57
Assess the safety of EMP-01 compared with placebo (PBO) in participants with SAD.
1 secondary outcome
Liebowitz Social Anxiety Scale (LSAS)
Time frame: Baseline to EOS [Day 43]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Social Anxiety Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Recruiting
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
Caregiver Anxiety, Acquired Brain Injury
Not yet recruiting
Online Study on the Impact of a Self-Help Tool for Social Anxiety
Social Anxiety
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EMP-01 in people with Social Anxiety Disorder, run by atai Therapeutics, Inc. at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment emergent adverse events, adverse events of special interest and serious adverse events. (time frame: Day 1 to EOS [Day 43]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.