Combination Of PAXIL Tablet And Benzodiazepines - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00259883

Purpose

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	Intervention	Phase
Mental Disorders Depression	Drug: paroxetine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Depression Mental Disorders Psychotic Disorders

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine hydrochloride hemihydrate Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

The rate and extent of decrease in Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	150
Study Start Date:	June 2005
Study Completion Date:	February 2006
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: paroxetine paroxetine 20 to 40mg/day	Drug: paroxetine 1 or 2 tablets once a day Other Name: paroxetine

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259883

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00259883 History of Changes
Other Study ID Numbers:	104228
Study First Received:	November 30, 2005
Last Updated:	August 25, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

depressive episodes
paroxetine
PAXIL

depression
benzodiazepine
combination

Additional relevant MeSH terms:

Mental Disorders
Psychotic Disorders
Depression
Depressive Disorder
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms
Mood Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012