Major Depressive Disorder (MDD
Conditions
Brief summary
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Major Depressive 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 (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 major depressive 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 whose current depressive episode has lasted for at least 2 months but no more than 12 months 6. Participants with a HAM-D17 (Hamilton depression rating scale 17 items) total score of 18 or higher and a CGI-S (Clinical global impression-Improvement) 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 major depressive 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 major depressive disorder with mixed features, psychotic features, or catatonia as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) * Participants with a current 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 or personality disorders as defined by DSM-5-TR (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision) * Participants with a current or past history of clinically significant neurological disorders (including epilepsy) * Participants with neurodegenerative diseases (such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc.) 2. Participants who, in the opinion of the principal (or sub-investigator), have not responded to at least two different antidepressants, each administered at an adequate dose for at least 6 weeks, during the current or past depressive episode. 3. Participants who have used adjunctive treatments such as lithium, triiodothyronine/thyroxine, lamotrigine, valproate, carbamazepine, or atypical antipsychotics, or who have used combination therapy with antidepressants for the current depressive episode.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HAM-D17(Hamilton depression rating scale 17 items) total score from baseline to Week 8 of the treatment period | Up to 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The transition of HAM-D17(Hamilton depression rating scale 17 items) total score from baseline to Week 8 of the treatment period | Up to 16 weeks | — |
| Responder rates of HAM-D17(Hamilton depression rating scale 17 items) total score at 1, 2, 4, 6, and 8 weeks of the treatment period | Up to 16 weeks | Responder is defined as a reduction of 50% or more in HAM-D17(Hamilton depression rating scale 17 items) total score from baseline |
| Remitted patient rates of HAM-D17(Hamilton depression rating scale 17 items) score at 1, 2, 4, 6, and 8 weeks of the treatment period | Up to 16 weeks | Remitted patient is defined as a total HAM-D17(Hamilton depression rating scale 17 items) total score of 7 or less. |
| Change in the total MADRS(Montgomery-Åsberg depression rating scale) score from baseline to Week 8 of the treatment period | Up to 16 weeks | — |
| Transition of HAM-A(Hamilton Anxiety Scale) total score from baseline to Week 8 of the treatment period | Up to 16 weeks | — |
| Transition of CGI-S(Clinical Global Impression of illness Severity) score from baseline to Week 8 of the treatment period | Up to 16 weeks | — |
| Transition of QIDS-J(Quick Inventory of Depressive Symptomatology) total score from baseline to Week 8 of the treatment period | Up to 16 weeks | — |
| Transition of CGI-I(Clinical Global Impression of Impression Important) score from baseline to Week 8 of the treatment period | Up to 16 weeks | — |
| Plasma ONO-1110 concentrations | Up to 16 weeks | — |
| Adverse Events | Up to 16 weeks | — |
Countries
Japan
Contacts
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co., Ltd.
Outcome results
None listed