Combination Of PAXIL Tablet And Benzodiazepines
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...
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”
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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: February 2006
Intervention(s) in this Clinical Trial
- Drug: paroxetine
- 1 or 2 tablets once a day
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: paroxetine
- paroxetine 20 to 40mg/day
Outcome Measures for this Clinical Trial
Primary Measures
- The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D)
- Time Frame: 8 weeks
Safety Issue?: No
- Time Frame: 8 weeks
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.
- Time Frame: 8 weeks
Safety Issue?: No
- Time Frame: 8 weeks
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 Investigator Information
Lead Investigator: GlaxoSmithKline Industry
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on February 02, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00259883
