A Study of MD-120 in Patients With Depression

Mochida Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: Desvenlafaxine 100 mg; Drug: Desvenlafaxine 50 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04345471

MD120101

JapicCTI-205252 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to verify the efficacy and evaluate the safety of 8-week once-daily oral administration of MD-120 in Japanese patients with depression.

Enrollment: 615 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with diagnosis of Major Depressive Disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5).
• Hamilton Depression Rating Scale-17 (HAM-D17) total score of ≥20.

Exclusion criteria

• Patient who meets DSM-5 criteria of the following disorders for current or past history.

Schizophrenia spectrum and other psychotic disorders Bipolar and related disorders Substance use disorders (exclusive of tobacco and caffeine)

• Patient who had suicidal behavior in Columbia-Suicide Severity Rating Scale (C-SSRS) within 1 year before start of screening phase.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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615 participants in 3 patient groups, including a placebo group

MD-120 100 mg

Experimental group

Treatment:

Drug: Desvenlafaxine 100 mg

MD-120 50 mg

Experimental group

Treatment:

Drug: Desvenlafaxine 50 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo