Evaluating ONO-1110 for Social Anxiety Disorder

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

This study is testing a new medication called ONO-1110 to see if it can help people with social anxiety disorder feel less anxious and function better in their daily lives.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ono Pharmaceutical Co. Ltd (Industry-sponsored)
• Locations: 1 site (Fukuoka)
• Trial ID: NCT06805565 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of ONO-1110 in treating patients diagnosed with social anxiety disorder (SAD). Participants will be randomly assigned to receive either ONO-1110 or a placebo, with their responses evaluated using standardized psychiatric assessments. The study focuses on Japanese outpatients who meet specific diagnostic criteria for SAD, ensuring a targeted approach to treatment. The trial will monitor participants for improvements in anxiety symptoms and overall functioning.

Who should consider this trial

Good fit: Ideal candidates for this study are Japanese outpatients diagnosed with social anxiety disorder who have a high level of anxiety as indicated by specific scoring criteria.

Not a fit: Patients with comorbid psychiatric disorders or those who do not meet the specific diagnostic criteria for social anxiety disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from social anxiety disorder.

How similar studies have performed: While there have been studies on various treatments for social anxiety disorder, the specific approach using ONO-1110 is novel and has not been extensively tested in prior research.

Eligibility criteria

Inclusion 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 (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:

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 (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

Where this trial is running

Fukuoka

• Kokura Mental Clinic — Fukuoka, Japan (Recruiting)

Study contacts

• Study coordinator: Ono Pharmaceutical Co., Ltd

Conditions Social Anxiety Disorder