A Study of ONO-1110 in Patients With Social Anxiety Disorder

Inclusion Criteria:

1. Japanese participants (sex not specified)

2. Participants who, in the opinion of the principal (or sub-investigator), are capableof understanding the content of the clinical trial and complying with itsrequirements

3. Participants diagnosed with social anxiety disorder based on DSM-5-TR (Diagnosticand Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) criteria,as determined through an interview using the M.I.N.I. (Mini-internationalneuropsychiatric interview)

4. Outpatients

5. Participants with a LSAS-J (Liebowitz Social Anxiety Scale Japanese version) totalscore of 70 or higher and a CGI-S (Clinical global impression-Severity) score of 4or higher

Exclusion Criteria:

1. Participants with a current or past history of psychiatric or neurological disordersthat meet any of the following criteria:

• Participants with a comorbid psychiatric disorder other than social anxietydisorder as defined by DSM-5-TR (Diagnostic and Statistical Manual of MentalDisorders, Fifth Edition, Text Revision) (assessed using the M.I.N.I. (Mini-international neuropsychiatric interview))

• Participants with a comorbid or past history of schizophrenia or otherpsychotic disorders as defined by DSM-5-TR (Diagnostic and Statistical Manualof Mental Disorders, Fifth Edition, Text Revision)

• Participants with neurodevelopmental disorders, neurocognitive disorders, orpersonality disorders (excluding avoidant personality disorder) as defined byDSM-5-TR

2. Participants who have been primarily diagnosed with a disorder other than socialanxiety disorder according to DSM-5-TR (Diagnostic and Statistical Manual of MentalDisorders, Fifth Edition, Text Revision) criteria within 24 weeks prior to screening

3. Participants with a MADRS (Montgomery Åsberg Depression Rating Scale) total score of 15 or higher

4. Participants who, in the opinion of the principal (or sub-investigator), have notresponded to at least two different SSRIs (Selective serotonin reuptake inhibitor),each administered at an adequate dose for at least 10 weeks, in treating socialanxiety disorder