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NCT00259883 Clinical Trial

Combination Of PAXIL Tablet And Benzodiazepines

Mental Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00259883
Other study ID # 104228
Secondary ID
Status Completed
Phase Phase 4
First received November 30, 2005
Last updated January 16, 2017
Start date June 2005
Est. completion date February 2006

Study information
Verified date January 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date February 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• paroxetine
1 or 2 tablets once a day

Locations
Country Name City State
GSK Investigational Site

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Outcome
Type Measure Description Time frame Safety issue
Primary The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D) 8 weeks
Secondary 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. 8 weeks
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