Major Depressive Disorder (MDDPhase 2NCT06792136
A Study of ONO-1110 in Patients With Major Depressive Disorder
A Phase 2 study testing ONO-1110 in people with Major Depressive Disorder (MDD, run by Ono Pharmaceutical Co., Ltd. at 29 sites in Japan.
Trial summary
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Major Depressive Disorder Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD
- What is being tested?
- ONO-1110
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 29 sitesJapan
- Study dates
- 16 Jan 2025to 9 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Japan29 sites
AK Clinic
Fukuoka
Hiro Mental Clinic
Fukuoka
Hirota Clinic
Fukuoka
Kokorono Clinic Hirao
Fukuoka
Kokorono Clinic Iizuka
Fukuoka
Kokura Mental Clinic
Fukuoka
Mental Clinic Sakurazaka
Fukuoka
Shinseikai Kaku Mental Clinic
Fukuoka
Uematsu Mental Clinic
Fukuoka
Ichikawa Clinic
Gunma
Higashi-Sapporo Mental Clinic
Hokkaido
Kawamura Mental Clinic
Hokkaido
Minami1jo Mental Clinic
Hokkaido
Sapporo Kobushi Clinic
Hokkaido
Shimode Mental Clinic
Hokkaido
Tatsuta Clinic
Hyōgo
Kishiro Mental Clinic
Kanagawa
Yutaka Clinic
Kanagawa
Harai Clinic
Tokyo
Iidabashi Mental Clinic
Tokyo
Ikebukuro Olive Mental Clinic
Tokyo
Kitaikebukuro Kokoro No Clinic
Tokyo
Maynds Tower Mental Clinic
Tokyo
Meguroeki Higashiguchi Mental Clinic
Tokyo
Monzen-nakacho Mental Clinic
Tokyo
Niseikai Murakami Iin
Tokyo
Nishi-Shinjuku Concieria Clinic
Tokyo
Sakurazaka Clinic SophyAnce
Tokyo
Sangenjaya Nakamura Mental Clinic
Tokyo
About this study
Official title: 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
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Major Depressive Disorder
- Conditions
- Major Depressive Disorder (MDD
- Being tested
- ONO-1110, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-1110Drug
ONO-1110 tablets once a day
PlaceboDrug
Placebo tablets once daily
| Study group | Role | What they receive |
|---|---|---|
| ONO-1110 | Experimental | Not described Receives: Drug: ONO-1110; Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: ONO-1110; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HAM-D17(Hamilton depression rating scale 17 items) total score from baseline to Week 8 of the treatment period
Measured: 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
Measured: 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
Responder is defined as a reduction of 50% or more in HAM-D17(Hamilton depression rating scale 17 items) total score from baseline
Measured: 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
Remitted patient is defined as a total HAM-D17(Hamilton depression rating scale 17 items) total score of 7 or less.
Measured: Up to 16 weeks
Change in the total MADRS(Montgomery-Åsberg depression rating scale) score from baseline to Week 8 of the treatment period
Measured: Up to 16 weeks
Transition of HAM-A(Hamilton Anxiety Scale) total score from baseline to Week 8 of the treatment period
Measured: Up to 16 weeks
Transition of CGI-S(Clinical Global Impression of illness Severity) score from baseline to Week 8 of the treatment period
Measured: Up to 16 weeks
Transition of QIDS-J(Quick Inventory of Depressive Symptomatology) total score from baseline to Week 8 of the treatment period
Measured: Up to 16 weeks
Transition of CGI-I(Clinical Global Impression of Impression Important) score from baseline to Week 8 of the treatment period
Measured: Up to 16 weeks
Plasma ONO-1110 concentrations
Measured: Up to 16 weeks
Adverse Events
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start16 Jan 2025
- Primary completion9 Apr 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDDStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792136
- Sponsor's protocol ID
- ONO-1110-07
- Other IDs
- jRCT2031240577
- Status last verified
- Jul 2026
- First submitted
- 19 Jan 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06792136
- Acronym / sponsor ID
- ONO-1110-07
- Conditions
- Major Depressive Disorder (MDD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Major Depressive Disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-1110 | Experimental | Drug: ONO-1110, Drug: Placebo |
| Placebo | Placebo comparator | Drug: ONO-1110, Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Participants with a current or past history of psychiatric or neurological disorders that meet any of the following criteria:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-1110ONO-1110 tablets once a day | Drug | ONO-1110, Placebo |
| PlaceboPlacebo tablets once daily | Drug | ONO-1110, Placebo |
Primary outcome
Change in HAM-D17(Hamilton depression rating scale 17 items) total score from baseline to Week 8 of the treatment period
Time frame: Up to 16 weeks
10 secondary outcomes
The transition of HAM-D17(Hamilton depression rating scale 17 items) total score from baseline to Week 8 of the treatment period
Time frame: 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
Time frame: 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
Time frame: Up to 16 weeks
Change in the total MADRS(Montgomery-Åsberg depression rating scale) score from baseline to Week 8 of the treatment period
Time frame: Up to 16 weeks
Transition of HAM-A(Hamilton Anxiety Scale) total score from baseline to Week 8 of the treatment period
Time frame: Up to 16 weeks
Transition of CGI-S(Clinical Global Impression of illness Severity) score from baseline to Week 8 of the treatment period
Time frame: Up to 16 weeks
Transition of QIDS-J(Quick Inventory of Depressive Symptomatology) total score from baseline to Week 8 of the treatment period
Time frame: Up to 16 weeks
Transition of CGI-I(Clinical Global Impression of Impression Important) score from baseline to Week 8 of the treatment period
Time frame: Up to 16 weeks
Plasma ONO-1110 concentrations
Time frame: Up to 16 weeks
Adverse Events
Time frame: Up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Project Leader study director
Ono Pharmaceutical Co., Ltd.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-1110 in people with Major Depressive Disorder (MDD, run by Ono Pharmaceutical Co., Ltd. at 29 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HAM-D17(Hamilton depression rating scale 17 items) total score from baseline to Week 8 of the treatment period (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.