A Phase 2 Trial of OPC-64005 for Major Depressive Disorder

Study Overview
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Brief Summary
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The objective of the trial is to compare the efficacy of OPC-64005 at 20 mg vs placebo and to assess the safety and pharmacokinetics of OPC-64005 at 10 and 20 mg in patients with major depressive disorder (MDD).The primary endpoint is the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 of the double-blind treatment period in the OPC-64005 20-mg group compared with the placebo group

Official Title
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A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison Trial to Assess Efficacy and Safety of OPC-64005 in Patients With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: OPC-64005 20 mg , Once-daily
* Drug: OPC-64005 10 mg , Once-daily
* Drug: Placebo, Once-daily


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a DSM-5 classification-based diagnosis of major depressive disorder, single episode or major depressive disorder, recurrent episode with the current episode persisting for ≥4 weeks to ≤1 year Patients with a total score of ≥18 on the 17-item Hamilton Rating Scale for Depression (HAM-D) Exclusion Criteria: Patients with a diagnosis of any of the following diseases according to DSM-5 Neurocognitive disorders, history or complication of schizophrenia spectrum or other psychotic disorder, history or complication of bipolar and related disorders, feeding and eating disorders, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, personality disorders, neurodevelopmental disorders, substance-related and addictive disorders (within 180 days prior to informed consent) Patients exhibiting mood-incongruent psychotic features in the current major depressive episode Patients who, in the opinion of the investigator or subinvestigator, are judged to have treatment-resistant depression, ie, a certain degree of therapeutic effect is not obtained by administration of 2 or more antidepressants having different mechanisms of action at sufficient doses for at least 6 weeks for the current major depressive episode Patients receiving augmentation treatment, such as antipsychotics, for the current major depressive episode (excluding the use of sulpiride for depression/depressive state or gastric/duodenal ulcer)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPC-64005 20 mg<br> | Drug: OPC-64005 20 mg , Once-daily<br>* Active, High Dose<br>|
| Experimental: OPC-64005 10 mg<br> | Drug: OPC-64005 10 mg , Once-daily<br>* Active, Low Dose<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo, Once-daily<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score | Mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate in MADRS total score | Responder is defined as subjects whose MADRS total score decrease 50% and more than 50% from baseline to Week 6. | Week 6 | 
| Remission rate in MADRS total score | Remission is defined as subjects whose MADRS total score decrease 50% and more than 50% from baseline to Week 6 and 10 points and less than 10 points at Week 6. | Week 6 | 
| Improvement rate in CGI-I score | Improvement is defined as subjects whose CGI-S score is 1 or 2 at Week 6 | Week 6 | 
| Mean change from baseline in CGI-S score | Mean change from baseline in CGI-S score | Week 6 | 
| Mean change from baseline in HAM-D 17 items total score | Mean change from baseline in HAM-D 17 items total score | Week 6 | 
| Mean change from baseline in Apathy Scale Score | Mean change from baseline in Apathy Scale Score | Week 6 | 
| Mean change from baseline in MADRS-S total score | Mean change from baseline in MADRS-S total score | Week 6 | 
| Mean change from baseline in anhedonia factor of MADRS | Anhedonia factor is defines as a total score of item 1, 2, 6, 7, and 8 of MADRS. | Week 6 |