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A Study of ONO-1110 in Patients With Major Depressive Disorder | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

NCT06792136•Ono Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (29)

AK Clinic

Fukuoka, Japan

Hiro Mental Clinic

Fukuoka, Japan

Hirota Clinic

Fukuoka, Japan

Kokorono Clinic Hirao

Fukuoka, Japan

Kokorono Clinic Iizuka

Fukuoka, Japan

Kokura Mental Clinic

Fukuoka, Japan

Mental Clinic Sakurazaka

Fukuoka, Japan

Shinseikai Kaku Mental Clinic

Fukuoka, Japan

Uematsu Mental Clinic

Fukuoka, Japan

Ichikawa Clinic

Gunma, Japan

Key Dates

Start Date

January 16, 2025

Primary Completion Date

August 31, 2026

Completion Date

August 31, 2026

Last Updated

February 20, 2026

Enrollment

100

ESTIMATED participants

Conditions

Major Depressive Disorder (MDD

Interventions

ONO-1110

DRUG

Placebo

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Group Therapy for Major Depression: Comparing Expectation-Focused and Reward-Focused Psychotherapy Approaches

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Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements