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ONO-1110-07: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 Major Depressive Disorder

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

Terasawa Tetsuji

Ono Pharmaceutical Co.,LTD.

1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan

clinical_trial@ono-pharma.com

JP Clinical Trial Support Desk

Ono Pharmaceutical Co.,LTD.

1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan

+81-120-278-120

clinical_trial@ono-pharma.com

Complete

Jan. 17, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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

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.

Both

Major Depressive Disorder

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.

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

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

+81-42-648-5551

Nov. 29, 2024

No

none