Study of Desvenlafaxine in Treating Major Depressive Disorder.

CSPC Pharmaceutical Group

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: Duloxetine Hydrochloride Enteric-coated Capsule

Drug: Desvenlafaxine Succinate Sustained-Release Tablet , Duloxetine Hydrochloride Enteric-coated Capsule Placebo

Drug: Duloxetine Hydrochloride Enteric-coated Capsule Placebo

Drug: Desvenlafaxine Succinate Sustained-Release Tablet Placebo, Duloxetine Hydrochloride Enteric-coated Capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT04364997

HF124-CSP-001

Details and patient eligibility

About

The primary purpose of this study is to evaluate if the effectiveness of desvenlafaxine succinate sustained-release tablet (50 mg/day) used for 8 weeks is not inferior to duloxetine hydrochloride enteric-coated capsule (60 mg/day) in adult patients with major depressive disorder.

Full description

This is a multicenter study to evaluate if the effectiveness of desvenlafaxine succinate sustained-release tablet (50 mg/day) used for 8 weeks is not inferior to duloxetine hydrochloride enteric-coated capsule (60 mg/day) in adult patients with major depressive disorder. A total of 400 subjects will be randomly allocated to experimental arm (desvenlafaxine succinate sustained-release tablet) and active comparator arm (duloxetine hydrochloride enteric-coated capsule) in a 1:1 ratio.

Enrollment

420 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 ≤ age ≤ 65 years old, male or female;
Outpatients and inpatients who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and Neuropsychiatric Interview5.0.0 (MINI5.0.0) for a primary diagnosis of Major Depressive Disorder(MDD), single or recurrent episode and measured by the Mini-International Neuropsychiatric Interview5.0.0 (MINI5.0.0) as active stage.
Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of >= 18.

Exclusion criteria

Hamilton Rating Scale for Anxiety (HAM-A) total score of > 14.
Refractory depression: Ineffective after adequate treatment with two or more antidepressants.
Current or previous diagnosis of Axis I with DSM-IV other than depression.
Significant risk of suicide based on clinical judgment or HAM-D 17, Suicide attempt in the past 6 months.
Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.