Social Anxiety Disorder (SAD)
Conditions
Brief summary
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Social Anxiety Disorder
Interventions
DRUGONO-1110
ONO-1110 tablets once a day
DRUGPlacebo
Placebo tablets once daily
Sponsors
Ono Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in L-SAS J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 12 of the treatment period | Up to 19 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The transition of LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score from baseline to Week 8 of the treatment period | 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 | 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 | 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 | Up to 19 weeks | Responder is defined as a reduction of 30% or more in LSAS-J(Liebowitz Social Anxiety Scale Japanese version)total score from baseline |
| 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 | Up to 19 weeks | Remitted patient is defined as a LSAS-J(Liebowitz Social Anxiety Scale Japanese version) total score of 30 or less. |
| Transition of CGI-S(Clinical Global Impression of illness Severity) score from baseline to Week 12 of the treatment period | Up to 19 weeks | — |
| Transition of SDISS(Sheehan Disability Scale) score from baseline to Week 12 of the treatment period | Up to 19 weeks | — |
| Plasma ONO-1110 concentrations | Up to 19 weeks | — |
| Adverse Events | Up to 19 weeks | — |
Countries
Japan
Contacts
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co., Ltd.
Outcome results
None listed