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

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

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

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: OPC-64005 20 mg , Once-daily; Drug: OPC-64005 10 mg , Once-daily; Drug: Placebo, Once-daily

• Study Type: Interventional
• Enrollment (Actual): 273
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Medical Corporation Jisenkai Himorogi Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6 of the Double-blind Treatment Period	The MADRS was a clinician-rated scale which evaluated the level of depression. The MADRS consists of following 10 depressive symptoms on 7 scales of 0 to 6, with higher scores indicating worse condition. 1. Apparent sadness, 2. Reported sadness, 3. Inner tension, 4. Reduced sleep, 5. Reduced appetite, 6. Concentration difficulties, 7. Lassitude, 8. Inability to feel, 9. Pessimistic thoughts, and 10. Suicidal thoughts Summed subscales were combined to compute a total score. Total score ranges form 0 to 60, with higher scores indicating worse condition.	Baseline, Week 1, 2, 3, 4, 5, and 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MADRS Response Rate	The MADRS response rate is the percentage of subjects with ≥50% reduction from baseline in MADRS total score at Week 6 of the double-blind treatment period.	Baseline, Week 1, 2, 3, 4, 5, and 6
MADRS Remission Rate	MADRS remission rate is the percentage of subjects with MADRS total score ≤ 10 and ≥ 50% reduction from baseline in MADRS total score at Week 6 of the double-blind treatment period.	Week6

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Investigators: Study Director: Takehisa Matsumaru, Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Actual): February 8, 2022
• Study Completion (Actual): February 25, 2022

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 26, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 277-102-00027; JapicCTI-205116 (Other Identifier: JapicCTI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No