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New depression drug shows promise in early trial

NCT ID NCT06792136

Symptom relief Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tests a new medicine called ONO-1110 in 100 Japanese adults with major depressive disorder. Participants receive either the drug or a placebo for 8 weeks. The main goal is to see if the drug reduces depression symptoms more than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

103 people

The number who actually took part.

Started

Jan 2025

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder (MDD)

Contacts and locations

Locations

  • AK Clinic

    Fukuoka, Japan

  • Harai Clinic

    Tokyo, Japan

  • Higashi-Sapporo Mental Clinic

    Hokkaido, Japan

  • Hiro Mental Clinic

    Fukuoka, Japan

  • Hirota Clinic

    Fukuoka, Japan

  • Ichikawa Clinic

    Gunma, Japan

  • Iidabashi Mental Clinic

    Tokyo, Japan

  • Ikebukuro Olive Mental Clinic

    Tokyo, Japan

  • Kawamura Mental Clinic

    Hokkaido, Japan

  • Kishiro Mental Clinic

    Kanagawa, Japan

  • Kitaikebukuro Kokoro No Clinic

    Tokyo, Japan

  • Kokorono Clinic Hirao

    Fukuoka, Japan

  • Kokorono Clinic Iizuka

    Fukuoka, Japan

  • Kokura Mental Clinic

    Fukuoka, Japan

  • Maynds Tower Mental Clinic

    Tokyo, Japan

  • Meguroeki Higashiguchi Mental Clinic

    Tokyo, Japan

  • Mental Clinic Sakurazaka

    Fukuoka, Japan

  • Minami1jo Mental Clinic

    Hokkaido, Japan

  • Monzen-nakacho Mental Clinic

    Tokyo, Japan

  • Niseikai Murakami Iin

    Tokyo, Japan

  • Nishi-Shinjuku Concieria Clinic

    Tokyo, Japan

  • Sakurazaka Clinic SophyAnce

    Tokyo, Japan

  • Sangenjaya Nakamura Mental Clinic

    Tokyo, Japan

  • Sapporo Kobushi Clinic

    Hokkaido, Japan

  • Shimode Mental Clinic

    Hokkaido, Japan

  • Shinseikai Kaku Mental Clinic

    Fukuoka, Japan

  • Tatsuta Clinic

    Hyōgo, Japan

  • Uematsu Mental Clinic

    Fukuoka, Japan

  • Yutaka Clinic

    Kanagawa, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.