A Study of ONO-1110 in Patients With Social Anxiety Disorder

Phase 2Active Not RecruitingNCT06805565

Ono Pharmaceutical Co., Ltd.100 enrolled

Overview

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Social Anxiety Disorder

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Social Anxiety Disorder (SAD)

Interventions

ONO-1110DRUG

ONO-1110 tablets once a day

PlaceboDRUG

Placebo tablets once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (27)

Aisakura Clinic

Fukuoka, Japan

AK Clinic

Fukuoka, Japan

Outcomes

Primary Outcomes

Change in L-SAS J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 12 of the treatment period

Time frame: Up to 19 weeks

Secondary Outcomes

The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 8 of the treatment period

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: Up to 19 weeks

Transition of CGI-S(Clinical Global Impression of illness Severity) score from baseline to Week 12 of the treatment period

Time frame: Up to 19 weeks

Transition of SDISS(Sheehan Disability Scale) score from baseline to Week 12 of the treatment period

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.