A Study of Sustained-Release Desvenlafaxine Hydrochloride for the Treatment of Major Depressive Disorder

Hansoh Pharma

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Sustained-Release Desvenlafaxine Hydrochloride; Drug: Sustained-Release Venlafaxine Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01977378

DVS20130806

Details and patient eligibility

About

A multicenter, 10-week study to evaluate the efficacy and safety of Sustained-Release Desvenlafaxine Hydrochloride versus Sustained-Release venlafaxine Hydrochloride in adult with major depressive disorder.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult with primary diagnosis of Major Depressive Disorder
• Aged from 18 years to 65 years
• A primary diagnosis of Major Depressive Disorder based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features
• Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of ≧ 20
• Clinical Global Impressions Scale-Severity (CGI-S) score of ≧4

Exclusion criteria

• Known hypersensitivity to desvenlafaxine or venlafaxine
• Significant risk of suicide based on clinical judgment
• Women who were pregnant,breast-feeding,or planning to become pregnant during study
• Had a history of seizure disorder
• History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs
• Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
• Cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

Sustained-Release Desvenlafaxine Hydrochloride

Experimental group

Description:

50-100mg/d

Treatment:

Drug: Sustained-Release Desvenlafaxine Hydrochloride

Sustained-Release Venlafaxine Hydrochloride

Active Comparator group

Description:

75-225mg/d

Treatment:

Drug: Sustained-Release Venlafaxine Hydrochloride