Evaluating ONO-1110 for 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

This study is testing a new medication called ONO-1110 to see if it can help people with Major Depressive Disorder feel better compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ono Pharmaceutical Co. Ltd (Industry-sponsored)
• Locations: 1 site (Fukuoka)
• Trial ID: NCT06792136 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of ONO-1110 in patients diagnosed with Major Depressive Disorder (MDD). Participants will be outpatients who meet specific diagnostic criteria and will receive either ONO-1110 or a placebo. The study will utilize standardized assessment tools, including the Hamilton Depression Rating Scale and Clinical Global Impression, to evaluate treatment outcomes over a defined period. The trial is designed to gather data on the potential benefits of ONO-1110 in alleviating depressive symptoms.

Who should consider this trial

Good fit: Ideal candidates for this study are Japanese outpatients diagnosed with Major Depressive Disorder who have experienced a depressive episode lasting between 2 to 12 months.

Not a fit: Patients with a history of significant psychiatric or neurological disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from Major Depressive Disorder.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in exploring new treatments for Major Depressive Disorder.

Eligibility criteria

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.

Where this trial is running

Fukuoka

• Kokura Mental Clinic — Fukuoka, Japan (Recruiting)

Study contacts

• Study coordinator: Ono Pharmaceutical Co., Ltd

Conditions Major Depressive Disorder (MDD