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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04244253
• Other study ID #: 277-102-00027
• Secondary ID: JapicCTI-205116
• Status: Completed
• Phase: Phase 2
• Start date: March 3, 2020
• Est. completion date: February 25, 2022

Study information

• Verified date: September 2022
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: February 25, 2022
• Est. primary completion date: February 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• OPC-64005 20 mg , Once-daily
Active, High Dose
• OPC-64005 10 mg , Once-daily
Active, Low Dose
• Placebo, Once-daily
Placebo

Locations

Country	Name	City	State
Japan	Medical Corporation Jisenkai Himorogi Psychiatric Institute	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Improvement rate in CGI-I score	Improvement is defined as subjects whose CGI-S score is 1 or 2 at Week 6	Week 6
Secondary	Mean change from baseline in CGI-S score	Mean change from baseline in CGI-S score	Week 6
Secondary	Mean change from baseline in HAM-D 17 items total score	Mean change from baseline in HAM-D 17 items total score	Week 6
Secondary	Mean change from baseline in Apathy Scale Score	Mean change from baseline in Apathy Scale Score	Week 6
Secondary	Mean change from baseline in MADRS-S total score	Mean change from baseline in MADRS-S total score	Week 6
Secondary	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