Combination Of PAXIL Tablet And Benzodiazepines - Full Text View

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
Depression	Drug: paroxetine	Phase IV

MedlinePlus related topics:

Depression

ChemIDplus related topics:

Paroxetine Paroxetine hydrochloride Paroxetine Mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by GlaxoSmithKline:

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.

Estimated Enrollment:	150
Study Start Date:	May 2005

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

Locations


Japan
	GSK Clinical Trials Call Center
	Chiba, Japan, 270
	GSK clinical trials call center
	Tokyo, Japan, 185
	GSK clinical trials call center
	Tokyo, Japan, 184
	GSK clinical trials call center
	Tokyo, Japan, 143
	GSK clinical trials call center
	Tokyo, Japan, 136
	GSK clinical trials call center
	Tokyo, Japan, 104
	GSK clinical trials call center
	Chiba, Japan, 260
	GSK clinical trials call center
	Hyogo, Japan, 662
	GSK clinical trials call center
	Osaka, Japan, 559
	GSK clinical trials call center
	Saitama, Japan, 336
	GSK clinical trials call center
	Tokyo, Japan, 205
	GSK clinical trials call center
	Tokyo, Japan, 150
	GSK Clinical Trials Call Center
	Tokyo, Japan, 154
	GSK clinical trials call center
	Chiba, Japan, 278
	GSK clinical trials call center
	Tokyo, Japan, 116
	GSK clinical trials call center
	Tokyo, Japan, 101
	GSK clinical trials call center
	Tokyo, Japan, 106
	GSK clinical trials call center
	Tokyo, Japan, 180
	GSK clinical trials call center
	Tokyo, Japan, 141
	GSK clinical trials call center
	Kanagawa, Japan, 220
	GSK clinical trials call center
	Tokyo, Japan, 139
	GSK clinical trials call center
	Kanagawa, Japan, 228
	GSK clinical trials call center
	Kanagawa, Japan, 230
	GSK clinical trials call center
	Kanagawa, Japan, 226
	GSK clinical trials call center
	Saitama, Japan, 341
	GSK clinical trials call center
	Shizuoka, Japan, 410
	GSK clinical trials call center
	Chiba, Japan, 272
	GSK clinical trials call center
	Osaka, Japan, 530
	GSK clinical trials call center
	Osaka, Japan, 536
	GSK clinical trials call center
	Osaka, Japan, 574
	GSK clinical trials call center
	Fukushima, Japan, 964
	GSK clinical trials call center
	Fukushima, Japan, 960
	GSK clinical trials call center
	Fukushima, Japan, 963
	GSK clinical trials call center
	Tokyo, Japan, 158
	GSK clinical trials call center
	Tokyo, Japan, 121

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	104228
First Received:	November 30, 2005
Last Updated:	April 25, 2006
ClinicalTrials.gov Identifier:	NCT00259883
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

PAXIL

paroxetine

depression

benzodiazepine

combination

depressive episodes

Study placed in the following topic categories:

Depression

Mental Disorders

Mood Disorders

Depressive Disorder

Paroxetine

Serotonin

Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Serotonin Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Serotonin Uptake Inhibitors

Antidepressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

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