Clinical trial NCT06805565: A Study of ONO-1110 in Patients With Social Anxiety Disorder
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Social Anxiety Disorder (SAD)
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2025-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change in L-SAS J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 12 of the treatment period
timeFrame: Up to 19 weeks
Secondary outcomes:
measure: The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 8 of the treatment period
timeFrame: Up to 19 weeks
measure: The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) Fear or Anxiety score from baseline to Week 8 of the treatment period
timeFrame: Up to 19 weeks
measure: The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) Avoidance score from baseline to Week 8 of the treatment period
timeFrame: Up to 19 weeks
measure: 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
timeFrame: Up to 19 weeks
measure: 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
timeFrame: Up to 19 weeks
measure: Transition of CGI-S(Clinical Global Impression of illness Severity) score from baseline to Week 12 of the treatment period
timeFrame: Up to 19 weeks
measure: Transition of SDISS(Sheehan Disability Scale) score from baseline to Week 12 of the treatment period
timeFrame: Up to 19 weeks
measure: Plasma ONO-1110 concentrations
timeFrame: Up to 19 weeks
measure: Adverse Events
timeFrame: Up to 19 weeks
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Kokura Mental Clinic
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: