NCT Number: NCT00474708
Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Beijing, Beijing Municipality, China
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
SSRI
DrugPrimary outcomes
-
Number of Patients Achieving Remission
Time frame: 12 weeks
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.
Secondary outcomes
-
Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)
Time frame: 12 weeks
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.
Sponsors and collaborators
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2007
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- May 17, 2007
- Registry last updated
- Mar 5, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Rapid Antidepressant Improvement Secondary to Excitatory Brain Responses
NCT04276259
Behavior, Behavioral Symptoms
Pittsburgh, Pennsylvania, United States
View Trial DetailsCBT+ for Depression
NCT06001346
Behavior, Behavioral Symptoms
Ames, Iowa, United States
View Trial DetailsIndividualized (fMRI-guided) TMS Treatment for Depression
NCT06266390
Behavior, Behavioral Symptoms
Philadelphia, Pennsylvania, United States
View Trial DetailsA Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder
NCT06267846
Behavior, Behavioral Symptoms
Little Rock, Arkansas, United States
View Trial Details