ONO-1110-07:Phase IIa study of ONO-1110 in Patients with Major Depressive Disorder

JRCT ID: jRCT2031240577

Registered date:23/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Major Depressive Disorder
• Date of first enrollment: 17/01/2025
• Target sample size: 100
• Study type: Interventional

Intervention(s)

The IMP is administered as follows according to the assigned administration group.
- ONO-1110 group: Take ONO-1110 tablets once a day.
- Placebo group: Take placebo tablets once daily.

Outcome(s)

Primary Outcome

Efficacy:
The change in the total HAM-D17 score from baseline

Secondary Outcome

Efficacy
Safety:
Adverse events, body weight, Vital signs, 12-lead electrocardiogram, Clinical laboratory test, C-SSRS
Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Terasawa Tetsuji