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Combination Of PAXIL Tablet And Benzodiazepines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00259883
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE November 30, 2005
First Posted Date  ICMJE December 1, 2005
Last Update Posted Date January 18, 2017
Study Start Date  ICMJE June 2005
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2011)
The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2005)
The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2011)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2005)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Of PAXIL Tablet And Benzodiazepines
Official Title  ICMJE Post-marketing Clinical Study on PAXIL Tablet in Patients With Depression or Depressive Mood - A Study on Combination of PAXIL Tablet and Benzodiazepines
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mental Disorders
Intervention  ICMJE Drug: paroxetine
1 or 2 tablets once a day
Study Arms  ICMJE Experimental: paroxetine
paroxetine 20 to 40mg/day
Intervention: Drug: paroxetine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2005)
150
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2006
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Japan
 
Administrative Information
NCT Number  ICMJE NCT00259883
Other Study ID Numbers  ICMJE 104228
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party GlaxoSmithKline
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE GlaxoSmithKline
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP