A Study of ONO-1110 in Patients With Major Depressive Disorder
NCT ID: NCT06792136
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-01-16
2026-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Placebo-Controlled Study of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder
NCT00514865
A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder
NCT06785012
Clinical Study to Test a New Drug to Treat Major Depression
NCT00976560
Phase 2b Study of ALTO-100 in MDD
NCT05712187
Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD
NCT05165394
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ONO-1110
ONO-1110
ONO-1110 tablets once a day
Placebo
Placebo tablets once daily
Placebo
ONO-1110
ONO-1110 tablets once a day
Placebo
Placebo tablets once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ONO-1110
ONO-1110 tablets once a day
Placebo
Placebo tablets once daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Project Leader
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Higashi-Sapporo Mental Clinic
Hokkaido, , Japan
Kawamura Mental Clinic
Hokkaido, , Japan
Minami1jo Mental Clinic
Hokkaido, , Japan
Sapporo Kobushi Clinic
Hokkaido, , Japan
Shimode Mental Clinic
Hokkaido, , Japan
Tatsuta Clinic
Hyōgo, , Japan
Kishiro Mental Clinic
Kanagawa, , Japan
Yutaka Clinic
Kanagawa, , Japan
Harai Clinic
Tokyo, , Japan
Iidabashi Mental Clinic
Tokyo, , Japan
Ikebukuro Olive Mental Clinic
Tokyo, , Japan
Kitaikebukuro Kokoro No Clinic
Tokyo, , Japan
Maynds Tower Mental Clinic
Tokyo, , Japan
Meguroeki Higashiguchi Mental Clinic
Tokyo, , 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
jRCT2031240577
Identifier Type: REGISTRY
Identifier Source: secondary_id
ONO-1110-07
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.