Major Depressive Disorder
Conditions
Sponsors
Terasawa Tetsuji
Eligibility
Sex/Gender
All
Inclusion 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 major depressive disorder based on DSM-5-TR criteria, as determined through an interview using the M.I.N.I. 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 total score of 18 or higher and a CGI-S score of 4 or higher
Exclusion criteria
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 (assessed using the M.I.N.I.) - Participants with major depressive disorder with mixed features, psychotic features, or catatonia as defined by DSM-5-TR - Participants with a current or past history of schizophrenia or other psychotic disorders as defined by DSM-5-TR - Participants with neurodevelopmental disorders or personality disorders as defined by DSM-5-TR - 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 |
|---|---|
| Efficacy: The change in the total HAM-D17 score from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Safety: Adverse events, body weight, Vital signs, 12-lead electrocardiogram, Clinical laboratory test, C-SSRS Pharmacokinetics | — |
Contacts
Public ContactSupport Desk JP
Ono Pharmaceutical Co.,LTD.
Outcome results
None listed