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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
First received
Last updated
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
Health authority
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)

Study Design


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
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