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

Phase 2

Recruiting

• Conditions: Major Depressive Disorder (MDD
• Interventions: Drug: ONO-1110; Drug: Placebo

• Registration Number: NCT06792136
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-16
• Study First Submitted: 2025-01-19
• Study First Submitted QC: 2025-01-19
• Study First Posted: 2025-01-24
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-01
• Last Update Posted: 2025-06-03
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ONO-1110	ONO-1110	-
ONO-1110	Placebo	-
Placebo	Placebo	-
Placebo	ONO-1110	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	Responder is defined as a reduction of 50% or more in HAM-D17(Hamilton depression rating scale 17 items) total score from baseline
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	Remitted patient is defined as a total HAM-D17(Hamilton depression rating scale 17 items) total score of 7 or less.
Transition of CGI-I(Clinical Global Impression of Impression Important) score from baseline to Week 8 of the treatment period	Up to 16 weeks
Plasma ONO-1110 concentrations	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
Adverse Events	Up to 16 weeks

Trial Locations

Locations (1)

Kokura Mental Clinic; 🇯🇵 Fukuoka, Japan