ONO-1110-08:Phase IIa study of ONO-1110 in Patients with Social Anxiety Disorder

JRCT ID: jRCT2031240578

Registered date:23/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Social Anxiety Disorder
• Date of first enrollment: 17/01/2025
• Target sample size: 100
• Study type: Interventional

Intervention(s)

The IMP is administered as follows according to the assigned administration group.
- ONO-1110 group: Take ONO-1110 tablets once a day.
- Placebo group: Take placebo tablets once daily.

Outcome(s)

Primary Outcome

Efficacy:
The change in the total LSAS-J score from baseline

Secondary Outcome

Efficacy
Safety:
Adverse events, body weight, Vital signs, 12-lead electrocardiogram, Clinical laboratory test, C-SSRS
Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

1.Japanese participants (sex not specified)
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 criteria, as determined through an interview using the M.I.N.I.
4.Outpatients
5.Participants with a LSAS-J total score of 70 or higher and a CGI-S score of 4 or higher

Exclude criteria

1.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 (assessed using the M.I.N.I.)
- Participants with a comorbid or past history of schizophrenia or other psychotic disorders as defined by DSM-5-TR

Related Information

• Primary Sponsor: Terasawa Tetsuji