This study was designed to assess the efficacy and safety of combination therapy of PAXIL and benzodiazepine anxiolytics. PAXIL Tablet will be administered to patients with depression or depressive episodes who have received Benzodiazepines for at least 4 weeks, and changes in the symptoms of depression will be evaluated by use of the rate and extent of decrease in Hamilton Rating Scale for...
Date First Received: November 30, 2005
Last Updated: October 15, 2008
Verified by: GlaxoSmithKline, October 2008
Clinical Trial Phase: Phase 4 | Start Date: June 2005
Overall Status: Completed
Estimated Enrollment: 150
Brief Summary
Official Title: “Post-Marketing Clinical Study on PAXIL Tablet in Patients With Depression or Depressive Mood - A Study on Combination of PAXIL Tablet and Benzodiazepines”
Condition Keyword(s):
Intervention(s):
This study was designed to assess the efficacy and safety of combination therapy of PAXIL and benzodiazepine anxiolytics. PAXIL Tablet will be administered to patients with depression or depressive episodes who have received Benzodiazepines for at least 4 weeks, and changes in the symptoms of depression will be evaluated by use of the rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D).
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: paroxetine
Outcome Measures for this Clinical Trial
Primary Measures
- The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D)
Secondary Measures
- The rate and extent of decrease in each item of HAM-D. The rate and extent of decrease of SRQ-D. Percentage of subjects who started tapering Benzodiazepine dose. Success rate in Benzodiazepine tapering Extent increase of SF-8. CGI responder rate.
Criteria for Participation in this Clinical Trial
Inclusion criteria:
- Patients with depression or depressive episodes who are diagnosed to have major depressive disorders according to the DSM-IV criteria.
- Patients with 14 or higher points in total scores for Items No.1 - 17 on HAM-D.
- Patients who have continuously received Benzodiazepine anxiolytics.
Exclusion criteria:
- Patients with a strong suicide tendency.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 64 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GlaxoSmithKline
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on February 04, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00259883
Study ID Number: 104228
ClinicalTrials.gov Identifier: NCT00259883
Health Authority: Japan: Ministry of Health, Labor and Welfare
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
