Clinical trial NCT06792136: A Study of ONO-1110 in Patients With Major Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Major Depressive Disorder (MDD
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2025-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To Evaluate the Efficacy and Safety of ONO-1110 in Patients with 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.

Primary outcomes:
measure: Change in HAM-D17(Hamilton depression rating scale 17 items) total score from baseline to Week 8 of the treatment period
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: The transition of HAM-D17(Hamilton depression rating scale 17 items) total score from baseline to Week 8 of the treatment period
timeFrame: Up to 16 weeks
measure: 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
timeFrame: Up to 16 weeks
measure: 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
timeFrame: Up to 16 weeks
measure: Change in the total MADRS(Montgomery-Åsberg depression rating scale) score from baseline to Week 8 of the treatment period
timeFrame: Up to 16 weeks
measure: Transition of HAM-A(Hamilton Anxiety Scale) total score from baseline to Week 8 of the treatment period
timeFrame: Up to 16 weeks
measure: Transition of CGI-S(Clinical Global Impression of illness Severity) score from baseline to Week 8 of the treatment period
timeFrame: Up to 16 weeks
measure: Transition of QIDS-J(Quick Inventory of Depressive Symptomatology) total score from baseline to Week 8 of the treatment period
timeFrame: Up to 16 weeks
measure: Transition of CGI-I(Clinical Global Impression of Impression Important) score from baseline to Week 8 of the treatment period
timeFrame: Up to 16 weeks
measure: Plasma ONO-1110 concentrations
timeFrame: Up to 16 weeks
measure: Adverse Events
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Kokura Mental Clinic
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: