Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients

Study Overview
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Brief Summary
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This study is an open-label, randomized, multi-center study conducted in a typical psychiatric outpatient practice in China. This study is intended to collect data on the efficacy and safety of venlafaxine XR (Efexor XR®) versus SSRIs and conventional antidepressants in depressed patients that previously failed antidepressant treatment. This data will be used to guide psychiatrists on recommendations for clinic use.

Official Title
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The Efficacy of Venlafaxine XR (Efexor XR®) Versus SSRIs & Conventional Antidepressants in Depressed Patients Switched From Prior Antidepressants in Psychiatric Outpatient Care Settings in China

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Effexor
* Drug: SSRI


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Males or females, 18 -65 years of age Outpatients Major depressive disorder based on DSM-IV criteria The baseline score of 17-item HAM-D³17 Switchers from prior antidepressants, who have had no satisfactory improvement (normally after a minimum of 8weeks of treatment), with an approved antidepressant medication or have experienced intolerance due to side effects to their antidepressant medication based on clinical discretion Provide written informed consent If female is of childbearing potential, must be confirmed no pregnancy at baseline, and use a medically acceptable method of contraception throughout the study. Main Exclusion Criteria: Hypersensitivity to venlafaxine; Clinically significant renal or hepatic disease or any other medical disease that, in the opinion of the investigator, might compromise the study, including seizure Alcohol or drug abuse within the last year A recent history of myocardial infarction or unstable heart disease (within 6 months of baseline) Bipolar disorder For female, known or suspected pregnancy or breast feeding Use of a monoamine oxidase inhibitor (MAOI) within 14 days of baseline; use of any investigational drug within 30 days of baseline. Patients have prior use of venlafaxine or use of venlafaxine for the current episode.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1.Effexor XR Group | Drug: Effexor<br> <br> |
| Active Comparator: 2<br>2.SSRI or Conventional Antidepressant Group | Drug: SSRI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Achieving Remission | Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status) | Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50. | 12 weeks |