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

Last updated: February 18, 2026
Sponsor: Ono Pharmaceutical Co. Ltd
Overall Status: Active - Not Recruiting

Phase

2

Condition

Anxiety Disorders

Social Anxiety Disorder (Sad)

Mood Disorders

Treatment

Placebo

ONO-1110

Clinical Study ID

NCT06805565
ONO-1110-08
jRCT2031240578
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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

  1. 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

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

  3. 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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
January 16, 2025
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Kokura Mental Clinic

    Fukuoka,
    Japan

    Site Not Available

  • AK Clinic

    Fukuoka 1863967,
    Japan

    Site Not Available

  • Aisakura Clinic

    Fukuoka 1863967,
    Japan

    Site Not Available

  • Hiro Mental Clinic

    Fukuoka 1863967,
    Japan

    Site Not Available

  • Hirota Clinic

    Fukuoka 1863967,
    Japan

    Site Not Available

  • Kokorono Clinic Hirao

    Fukuoka 1863967,
    Japan

    Site Not Available

  • Kokura Mental Clinic

    Fukuoka 1863967,
    Japan

    Site Not Available

  • Mental Clinic Sakurazaka

    Fukuoka 1863967,
    Japan

    Site Not Available

  • Shinseikai Kaku Mental Clinic

    Fukuoka 1863967,
    Japan

    Site Not Available

  • Uematsu Mental Clinic

    Fukuoka 1863967,
    Japan

    Site Not Available

  • Ichikawa Clinic

    Gunma,
    Japan

    Site Not Available

  • Higashi-Sapporo Mental Clinic

    Hokkaido,
    Japan

    Site Not Available

  • Kawamura Mental Clinic

    Hokkaido,
    Japan

    Site Not Available

  • Minami1jo Mental Clinic

    Hokkaido,
    Japan

    Site Not Available

  • Sapporo Kobushi Clinic

    Hokkaido,
    Japan

    Site Not Available

  • Shimode Mental Clinic

    Hokkaido,
    Japan

    Site Not Available

  • Tatsuta Clinic

    Hyōgo 2129969,
    Japan

    Site Not Available

  • Yutaka Clinic

    Kanagawa 1860292,
    Japan

    Site Not Available

  • Fukuoka

    Kitakyushu,
    Japan

    Site Not Available

  • Ai Clinic

    Miyazaki 1856717,
    Japan

    Site Not Available

  • Inoue Clinic

    Osaka 1853909,
    Japan

    Site Not Available

  • Yamaguchi Mental Clinic

    Tokushima 1850158,
    Japan

    Site Not Available

  • Harai Clinic

    Tokyo 1850147,
    Japan

    Site Not Available

  • Iidabashi Mental Clinic

    Tokyo 1850147,
    Japan

    Site Not Available

  • Ikebukuro Olive Mental Clinic

    Tokyo 1850147,
    Japan

    Site Not Available

  • Maynds Tower Mental Clinic

    Tokyo 1850147,
    Japan

    Site Not Available

  • Meguroeki Higashiguchi Mental Clinic

    Tokyo 1850147,
    Japan

    Site Not Available

  • Monzen-nakacho Mental Clinic

    Tokyo 1850147,
    Japan

    Site Not Available

  • Sangenjaya Nakamura Mental Clinic

    Tokyo 1850147,
    Japan

    Site Not Available

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