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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225024

Enrollment

270

Registered

2020-01-20

Start date

2020-03-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Interventions

investigational material(s) Generic name etc : OPC-64005 10 mg tablet,OPC-64005 20 mg tablet INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Inv

Eligibility

Sex/Gender

All

Inclusion 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 and more than 4 weeks to 1 and less than 1 year - Patients with a total score of 18 and more than 18 on the 17-item Hamilton Rating Scale for Depression (HAM-D)

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
efficacy Montgomery-Asberg Depression Rating Scale	—

Secondary

Measure	Time frame
efficacy MADRS,CGI-I,CGI-S,HAM-D,MADRS-S,Apathy scale	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026