Back to resultsCombination Of PAXIL Tablet And Benzodiazepines
Primary Purpose
Mental Disorders
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
paroxetine
Sponsored by
About this trial
This is an interventional treatment trial for Mental Disorders focused on measuring depressive episodes, paroxetine, PAXIL, depression, benzodiazepine, combination
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
paroxetine
Arm Description
paroxetine 20 to 40mg/day
Outcomes
Primary Outcome Measures
The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D)
Secondary Outcome 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00259883
Brief Title
Combination Of PAXIL Tablet And Benzodiazepines
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
depressive episodes, paroxetine, PAXIL, depression, benzodiazepine, combination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
paroxetine
Arm Type
Experimental
Arm Description
paroxetine 20 to 40mg/day
Intervention Type
Drug
Intervention Name(s)
paroxetine
Intervention Description
1 or 2 tablets once a day
Primary Outcome Measure Information:
Title
The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
12. IPD Sharing Statement
Learn more about this trial
Combination Of PAXIL Tablet And Benzodiazepines
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