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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Mental Disorders Drug: paroxetine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

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Arms and Interventions
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Arm Intervention/treatment
Experimental: paroxetine
paroxetine 20 to 40mg/day
 Drug: paroxetine
1 or 2 tablets once a day


Outcome Measures
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Primary Outcome Measures :
  1. The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 8 weeks ]

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. [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259883


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00259883    
Other Study ID Numbers: 104228
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Keywords provided by GlaxoSmithKline:
depressive episodes
paroxetine
PAXIL
 depression
benzodiazepine
combination
Additional relevant MeSH terms:
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Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
 Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors