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

Otsuka

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: OPC-64005 20 mg , Once-daily; Drug: Placebo, Once-daily; Drug: OPC-64005 10 mg , Once-daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT04244253

JapicCTI-205116 (Other Identifier)

277-102-00027

Details and patient eligibility

About

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

Enrollment: 273 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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273 participants in 3 patient groups, including a placebo group

OPC-64005 20 mg

Experimental group

Treatment:

Drug: OPC-64005 20 mg , Once-daily

OPC-64005 10 mg

Experimental group

Treatment:

Drug: OPC-64005 10 mg , Once-daily

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo, Once-daily