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

NCT06792136 | Active Not Recruiting Phase 2

• 2 other identifiers: ONO-1110-07jRCT2031240577
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 29

Brief Summary

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

Conditions

Major Depressive Disorder (MDD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

• 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

• 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

Study Arms (2)

ONO-1110

EXPERIMENTAL

Drug: ONO-1110; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Drug: ONO-1110; Drug: Placebo

Interventions

ONO-1110 DRUG

ONO-1110 tablets once a day

ONO-1110; Placebo

Placebo DRUG

Placebo tablets once daily

ONO-1110; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Japanese (sex not specified)
• 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
• 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)
• Outpatients
• Participants whose current depressive episode has lasted for at least 2 months but no more than 12 months
• 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

You may not qualify if:

• 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.)
• 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.
• 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.

Sponsors & Collaborators

• Ono Pharmaceutical Co. Ltd: lead

Study Sites (29)

AK Clinic

Fukuoka, Japan

Location

Hiro Mental Clinic

Fukuoka, Japan

Location

Hirota Clinic

Fukuoka, Japan

Location

Kokorono Clinic Hirao

Fukuoka, Japan

Location

Kokorono Clinic Iizuka

Fukuoka, Japan

Location

Kokura Mental Clinic

Fukuoka, Japan

Location

Mental Clinic Sakurazaka

Fukuoka, Japan

Location

Shinseikai Kaku Mental Clinic

Fukuoka, Japan

Location

Uematsu Mental Clinic

Fukuoka, Japan

Location

Ichikawa Clinic

Gunma, Japan

Location

Higashi-Sapporo Mental Clinic

Hokkaido, Japan

Location

Kawamura Mental Clinic

Hokkaido, Japan

Location

Minami1jo Mental Clinic

Hokkaido, Japan

Location

Sapporo Kobushi Clinic

Hokkaido, Japan

Location

Shimode Mental Clinic

Hokkaido, Japan

Location

Tatsuta Clinic

Hyōgo, Japan

Location

Kishiro Mental Clinic

Kanagawa, Japan

Location

Yutaka Clinic

Kanagawa, Japan

Location

Harai Clinic

Tokyo, Japan

Location

Iidabashi Mental Clinic

Tokyo, Japan

Location

Ikebukuro Olive Mental Clinic

Tokyo, Japan

Location

Kitaikebukuro Kokoro No Clinic

Tokyo, Japan

Location

Maynds Tower Mental Clinic

Tokyo, Japan

Location

Meguroeki Higashiguchi Mental Clinic

Tokyo, Japan

Location

Monzen-nakacho Mental Clinic

Tokyo, Japan

Location

Niseikai Murakami Iin

Tokyo, Japan

Location

Nishi-Shinjuku Concieria Clinic

Tokyo, Japan

Location

Sakurazaka Clinic SophyAnce

Tokyo, Japan

Location

Sangenjaya Nakamura Mental Clinic

Tokyo, Japan

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Project Leader

  Ono Pharmaceutical Co. Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 24, 2025
• Study Start: January 16, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (29)