A Study of ONO-1110 in Patients With Social Anxiety Disorder
NCT ID: NCT06805565
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-01-16
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ONO-1110
ONO-1110
ONO-1110 tablets once a day
Placebo
Placebo tablets once daily
Placeo
ONO-1110
ONO-1110 tablets once a day
Placebo
Placebo tablets once daily
Interventions
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ONO-1110
ONO-1110 tablets once a day
Placebo
Placebo tablets once daily
Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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)
4. Outpatients
5. 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
Exclusion Criteria
* Participants with a comorbid psychiatric disorder other than social anxiety disorder as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, 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 other psychotic disorders as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision)
* Participants with neurodevelopmental disorders, neurocognitive disorders, or personality disorders (excluding avoidant personality disorder) as defined by DSM-5-TR
2. 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
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 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
18 Years
65 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Project Leader
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Aisakura Clinic
Fukuoka, , Japan
AK Clinic
Fukuoka, , Japan
Hiro Mental Clinic
Fukuoka, , Japan
Hirota Clinic
Fukuoka, , Japan
Kokorono Clinic Hirao
Fukuoka, , Japan
Kokura Mental Clinic
Fukuoka, , Japan
Mental Clinic Sakurazaka
Fukuoka, , Japan
Shinseikai Kaku Mental Clinic
Fukuoka, , Japan
Uematsu Mental Clinic
Fukuoka, , Japan
Ichikawa Clinic
Gunma, , Japan
Higashi-Sapporo Mental Clinic
Hokkaido, , Japan
Kawamura Mental Clinic
Hokkaido, , Japan
Minami1jo Mental Clinic
Hokkaido, , Japan
Sapporo Kobushi Clinic
Hokkaido, , Japan
Shimode Mental Clinic
Hokkaido, , Japan
Tatsuta Clinic
Hyōgo, , Japan
Yutaka Clinic
Kanagawa, , Japan
Ai Clinic
Miyazaki, , Japan
Inoue Clinic
Osaka, , Japan
Yamaguchi Mental Clinic
Tokushima, , Japan
Harai Clinic
Tokyo, , Japan
Iidabashi Mental Clinic
Tokyo, , Japan
Ikebukuro Olive Mental Clinic
Tokyo, , Japan
Maynds Tower Mental Clinic
Tokyo, , Japan
Meguroeki Higashiguchi Mental Clinic
Tokyo, , Japan
Monzen-nakacho Mental Clinic
Tokyo, , Japan
Sangenjaya Nakamura Mental Clinic
Tokyo, , Japan
Countries
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Central Contacts
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Facility Contacts
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Kokura Mental Clinic
Role: primary
Other Identifiers
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jRCT2031240578
Identifier Type: REGISTRY
Identifier Source: secondary_id
ONO-1110-08
Identifier Type: -
Identifier Source: org_study_id
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