Study of Desvenlafaxine in Treating Major Depressive Disorder.

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Treatments: Desvenlafaxine Succinate; Duloxetine Hydrochloride

Criteria

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.