Active — Not RecruitingPhase 2

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

Japan100 participantsStarted 2025-01-16

Plain-language summary

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Social Anxiety Disorder

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Japanese participants (sex not specified)
✓. Participants who, in the opinion of the principal (or sub-investigator), are capable of understanding the content of the clinical trial and complying with its requirements
✓. Participants diagnosed with social anxiety disorder based on DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) criteria, as determined through an interview using the M.I.N.I. (Mini-international neuropsychiatric interview)
✓. Outpatients
✓. Participants with a LSAS-J (Liebowitz Social Anxiety Scale Japanese version) total score of 70 or higher and a CGI-S (Clinical global impression-Severity) score of 4 or higher

✕. Participants with a current or past history of psychiatric or neurological disorders that meet any of the following criteria:
✕. Participants who have been primarily diagnosed with a disorder other than social anxiety disorder according to DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) criteria within 24 weeks prior to screening
✕. Participants with a MADRS (Montgomery Åsberg Depression Rating Scale) total score of 15 or higher
✕. Participants who, in the opinion of the principal (or sub-investigator), have not responded to at least two different SSRIs (Selective serotonin reuptake inhibitor), each administered at an adequate dose for at least 10 weeks, in treating social anxiety disorder

Change in L-SAS J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 12 of the treatment period

Timeframe: Up to 19 weeks

NCT IDNCT06805565

SponsorOno Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-31

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Japanese participants (sex not specified)
✓. Participants who, in the opinion of the principal (or sub-investigator), are capable of understanding the content of the clinical trial and complying with its requirements
✓. Participants diagnosed with social anxiety disorder based on DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) criteria, as determined through an interview using the M.I.N.I. (Mini-international neuropsychiatric interview)
✓. Outpatients
✓. Participants with a LSAS-J (Liebowitz Social Anxiety Scale Japanese version) total score of 70 or higher and a CGI-S (Clinical global impression-Severity) score of 4 or higher

✕. Participants with a current or past history of psychiatric or neurological disorders that meet any of the following criteria:
✕. Participants who have been primarily diagnosed with a disorder other than social anxiety disorder according to DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) criteria within 24 weeks prior to screening
✕. Participants with a MADRS (Montgomery Åsberg Depression Rating Scale) total score of 15 or higher
✕. Participants who, in the opinion of the principal (or sub-investigator), have not responded to at least two different SSRIs (Selective serotonin reuptake inhibitor), each administered at an adequate dose for at least 10 weeks, in treating social anxiety disorder