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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

OPC-64005 20 mg , Once-daily

OPC-64005 10 mg , Once-daily

Placebo, Once-daily

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Medical Corporation Jisenkai Himorogi Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

OPC-64005 20 mg

OPC-64005 10 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score

Secondary Outcome Measures

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.

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.

Improvement rate in CGI-I score

Improvement is defined as subjects whose CGI-S score is 1 or 2 at Week 6

Mean change from baseline in CGI-S score

Mean change from baseline in HAM-D 17 items total score

Mean change from baseline in Apathy Scale Score

Mean change from baseline in MADRS-S total score

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.

Full Information

NCT ID

NCT04244253

First Posted

January 23, 2020

Last Updated

September 7, 2022

Sponsor

Otsuka Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04244253

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

March 3, 2020 (Actual)

Primary Completion Date

February 8, 2022 (Actual)

Study Completion Date

February 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

273 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OPC-64005 20 mg

Arm Type

Experimental

Arm Title

OPC-64005 10 mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

OPC-64005 20 mg , Once-daily

Intervention Description

Active, High Dose

Intervention Type

Drug

Intervention Name(s)

OPC-64005 10 mg , Once-daily

Intervention Description

Active, Low Dose

Intervention Type

Drug

Intervention Name(s)

Placebo, Once-daily

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score

Description

Mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score

Time Frame

Week 6

Secondary Outcome Measure Information:

Title

Responder rate in MADRS total score

Description

Responder is defined as subjects whose MADRS total score decrease 50% and more than 50% from baseline to Week 6.

Time Frame

Week 6

Title

Remission rate in MADRS total score

Description

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.

Time Frame

Week 6

Title

Improvement rate in CGI-I score

Description

Improvement is defined as subjects whose CGI-S score is 1 or 2 at Week 6

Time Frame

Week 6

Title

Mean change from baseline in CGI-S score

Description

Mean change from baseline in CGI-S score

Time Frame

Week 6

Title

Mean change from baseline in HAM-D 17 items total score

Description

Mean change from baseline in HAM-D 17 items total score

Time Frame

Week 6

Title

Mean change from baseline in Apathy Scale Score

Description

Mean change from baseline in Apathy Scale Score

Time Frame

Week 6

Title

Mean change from baseline in MADRS-S total score

Description

Mean change from baseline in MADRS-S total score

Time Frame

Week 6

Title

Mean change from baseline in anhedonia factor of MADRS

Description

Anhedonia factor is defines as a total score of item 1, 2, 6, 7, and 8 of MADRS.

Time Frame

Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Takehisa Matsumaru

Organizational Affiliation

Otsuka Pharmaceutical Co., Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Medical Corporation Jisenkai Himorogi Psychiatric Institute

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.

IPD Sharing Time Frame

Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.

IPD Sharing Access Criteria

Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Learn more about this trial

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

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