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History of Changes for Study: NCT00259883
Combination Of PAXIL Tablet And Benzodiazepines
Latest version (submitted January 16, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 30, 2005 None (earliest Version on record)
2 April 25, 2006 Recruitment Status, Study Status, Contacts/Locations, Study Description and Oversight
3 October 13, 2008 Recruitment Status, Study Status, Contacts/Locations and Sponsor/Collaborators
4 October 15, 2008 Study Status
5 October 5, 2010 Study Status and Study Identification
6 August 25, 2011 Arms and Interventions, Outcome Measures, Sponsor/Collaborators, Study Status, Contacts/Locations, Study Design and Conditions
7 April 11, 2013 Sponsor/Collaborators, Conditions and Study Status
8 January 16, 2017 Study Status and Contacts/Locations
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Results Submission Events
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Study NCT00259883
Submitted Date:  November 30, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: 104228
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
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2005
Overall Status: Recruiting
Study Start: May 2005
Primary Completion:
Study Completion:
First Submitted: November 30, 2005
First Submitted that
Met QC Criteria:
November 30, 2005
First Posted: December 1, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 30, 2005
Last Update Posted: December 1, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: GlaxoSmithKline
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: 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).
Detailed Description:
Open or close this module Conditions
Conditions: Depression
Keywords: PAXIL
paroxetine
depression
benzodiazepine
combination
depressive episodes
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 150
Open or close this module Arms and Interventions
Intervention Details:
Drug: paroxetine
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D)
Secondary Outcome Measures:
1. 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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 64 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: GSK Clinical Trial Call Center Refer to Study "104228"
Telephone: 1-877-379-3718
Study Officials: GSK Clinical Trials, MD
Study Director
GlaxoSmithKline
Locations: Japan
GSK clinical trials call center
[Recruiting]
Chiba, Japan, 260
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK Clinical Trials Call Center
[Recruiting]
Chiba, Japan, 270
Contact:Contact: GSK Clinical Trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Chiba, Japan, 272
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Chiba, Japan, 278
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Fukushima, Japan, 960
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Fukushima, Japan, 963
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Fukushima, Japan, 964
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Hyogo, Japan, 662
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Kanagawa, Japan, 220
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Kanagawa, Japan, 226
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Kanagawa, Japan, 228
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Kanagawa, Japan, 230
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Osaka, Japan, 530
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Osaka, Japan, 536
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Osaka, Japan, 559
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Osaka, Japan, 574
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Saitama, Japan, 336
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Saitama, Japan, 341
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Shizuoka, Japan, 410
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Tokyo, Japan, 101
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Tokyo, Japan, 104
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Tokyo, Japan, 106
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Tokyo, Japan, 116
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Tokyo, Japan, 121
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Tokyo, Japan, 136
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Tokyo, Japan, 139
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Tokyo, Japan, 141
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Tokyo, Japan, 143
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Tokyo, Japan, 150
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK Clinical Trials Call Center
[Recruiting]
Tokyo, Japan, 154
Contact:Contact: GSK Clinical Trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Tokyo, Japan, 158
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Tokyo, Japan, 180
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Tokyo, Japan, 184
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Tokyo, Japan, 185
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
GSK clinical trials call center
[Recruiting]
Tokyo, Japan, 205
Contact:Contact: GSK clinical trials Call Center 1-877-379-3718
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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