Phase 4
Completed N=1,158
Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients
Source: ClinicalTrials.gov NCT00474708 ↗Enrolled (actual)
1,158
Serious AEs
—
Results posted
Apr 2010
Primary outcomePrimary: Number of Patients Achieving Remission — 554; 207 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Achieving Remission |
554; 207 | — |
| SECONDARY Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status) |
60; 23; 494; 184 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00474708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.