Frontlight ResearchEarly access
CompletedPhase 2
A Study of ONO-1110 in Patients With Social Anxiety Disorder
Key facts
- Who runs it
- Ono Pharmaceutical Co., Ltd.
- Where
- Japan27 sites in 1 countryChoose a country to see its sites
- Trial code
- NCT06805565
- JRCT2031240578
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 115 people enrolled
- Started
- 31 Jan 2025
- Ended
- 25 May 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- ONO-1110
- Placebo
- Record updated
- 8 July 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 current or past history of psychiatric or neurological disorders that meet any of the following 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
- 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
- Participants with a MADRS (Montgomery Åsberg Depression Rating Scale) total score of 15 or higher
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Social Anxiety Disorder
The 2 groups in the trial
- ONO-1110Treatment being tested
Treatment: ONO-1110 and Placebo
- PlaceoPlacebo, for comparison
Treatment: ONO-1110 and Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Trial to Evaluate the Efficacy and Safety of ONO-1110 in Patients With Social Anxiety Disorder
- Record updated
- 8 July 2026