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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031240578 | Registry Identifier | Japan Registry of Clinical Trials |
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To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Social Anxiety Disorder
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-1110 | Experimental |
| |
| Placeo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-1110 | Drug | ONO-1110 tablets once a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in L-SAS J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 12 of the treatment period | Up to 19 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 8 of the treatment period | Up to 19 weeks | |
| The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) Fear or Anxiety score from baseline to Week 8 of the treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aisakura Clinic | Fukuoka | Japan | ||||
| AK Clinic |
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| Placebo |
| Drug |
Placebo tablets once daily |
|
| Up to 19 weeks |
| The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) Avoidance score from baseline to Week 8 of the treatment period | Up to 19 weeks |
| Responder rates of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score at 1, 2, 4, 6, 8,10and 2 weeks of the treatment period | Responder is defined as a reduction of 30% or more in LSAS-J(Liebowitz Social Anxiety Scale Japanese version)total score from baseline | Up to 19 weeks |
| Remitted patient rates of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score at 1, 2, 4, 6, 8, 10 and 12 weeks of the treatment period | Remitted patient is defined as a LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score of 30 or less. | Up to 19 weeks |
| Transition of CGI-S(Clinical Global Impression of illness Severity) score from baseline to Week 12 of the treatment period | Up to 19 weeks |
| Transition of SDISS(Sheehan Disability Scale) score from baseline to Week 12 of the treatment period | Up to 19 weeks |
| Plasma ONO-1110 concentrations | Up to 19 weeks |
| Adverse Events | Up to 19 weeks |
| 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 |
| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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