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

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind,Venlafaxine-Controlled Study of Efficacy and Safety of Sustained-Release Desvenlafaxine Hydrochloride in the Treatment of Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Sustained-Release Desvenlafaxine Hydrochloride
* Drug: Sustained-Release Venlafaxine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sustained-Release Desvenlafaxine Hydrochloride<br>50-100mg/d | Drug: Sustained-Release Desvenlafaxine Hydrochloride<br> <br> |
| Active Comparator: Sustained-Release Venlafaxine Hydrochloride<br>75-225mg/d | Drug: Sustained-Release Venlafaxine Hydrochloride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) |  | Baseline to Week 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline on the Clinical Global Impression Scale |  | Baseline to Week 10 | 
| Change From Baseline in Clinical Global Impression-Improvement (CGI-I) Scale |  | Baseline to Week 10 | 
| Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 10 |  | Baseline to Week 10 | 
| Change From Baseline in Adjusted Mean on Montgomery-Asberg Depression Rating Scale (MADRS) |  | Baseline to Week 10 | 
| Change From Baseline on the Visual Analogue Scale-Pain Intensity (VAS-PI) |  | Baseline to Week 10 | 
| Number of Participants in Remission Based on the HAM-D17 at Week 10 | Remission was defined as a HAM-D17 score of less than or equal to 7. | Baseline to Week 10 |