A Study of ONO-1110 in Patients With Major Depressive Disorder

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

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Major Depressive Disorder

Study Overview

• Status: Active, not recruiting
• Conditions: Major Depressive Disorder (MDD
• Intervention / Treatment: Drug: Placebo; Drug: ONO-1110

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • Hirota Clinic
  • Fukuoka, Japan
    • Kokura Mental Clinic
  • Fukuoka, Japan
    • AK Clinic
  • Fukuoka, Japan
    • Hiro Mental Clinic
  • Fukuoka, Japan
    • Kokorono Clinic Hirao
  • Fukuoka, Japan
    • Mental Clinic Sakurazaka
  • Fukuoka, Japan
    • Shinseikai Kaku Mental Clinic
  • Fukuoka, Japan
    • Uematsu Mental Clinic
  • Fukuoka, Japan
    • Kokorono Clinic Iizuka
  • Gunma, Japan
    • Ichikawa Clinic
  • Hokkaido, Japan
    • Higashi-Sapporo Mental Clinic
  • Hokkaido, Japan
    • Kawamura Mental Clinic
  • Hokkaido, Japan
    • Minami1jo Mental Clinic
  • Hokkaido, Japan
    • Sapporo Kobushi Clinic
  • Hokkaido, Japan
    • Shimode Mental Clinic
  • Hyōgo, Japan
    • Tatsuta Clinic
  • Kanagawa, Japan
    • Kishiro Mental Clinic
  • Kanagawa, Japan
    • Yutaka Clinic
  • Tokyo, Japan
    • Maynds Tower Mental Clinic
  • Tokyo, Japan
    • Harai Clinic
  • Tokyo, Japan
    • Iidabashi Mental Clinic
  • Tokyo, Japan
    • Ikebukuro Olive Mental Clinic
  • Tokyo, Japan
    • Meguroeki Higashiguchi Mental Clinic
  • Tokyo, Japan
    • Monzen-nakacho Mental Clinic
  • Tokyo, Japan
    • Sangenjaya Nakamura Mental Clinic
  • Tokyo, Japan
    • Kitaikebukuro Kokoro No Clinic
  • Tokyo, Japan
    • Niseikai Murakami Iin
  • Tokyo, Japan
    • Nishi-Shinjuku Concieria Clinic
  • Tokyo, Japan
    • Sakurazaka Clinic SophyAnce

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo tablets once daily; Drug: ONO-1110; ONO-1110 tablets once a day
Experimental: ONO-1110	Drug: Placebo; Placebo tablets once daily; Drug: ONO-1110; ONO-1110 tablets once a day

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma ONO-1110 concentrations		Up to 16 weeks
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	Responder is defined as a reduction of 50% or more in HAM-D17(Hamilton depression rating scale 17 items) total score from baseline	Up to 16 weeks
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	Remitted patient is defined as a total HAM-D17(Hamilton depression rating scale 17 items) total score of 7 or less.	Up to 16 weeks
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
Adverse Events		Up to 16 weeks

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: January 19, 2025
• First Posted (Actual): January 24, 2025

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: ONO-1110-07; jRCT2031240577 (Registry Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No