Combination Of PAXIL Tablet And Benzodiazepines - Full Text View

Sponsored by:	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
Depression	Drug: paroxetine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, 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

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Paroxetine Paroxetine hydrochloride 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)

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:	June 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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104228
Study First Received:	November 30, 2005
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00259883 History of Changes
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:

Neurotransmitter Agents
Depression
Mental Disorders
Psychotropic Drugs
Mood Disorders
Antidepressive Agents, Second-Generation

Depressive Disorder
Serotonin Uptake Inhibitors
Paroxetine
Antidepressive Agents
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Paroxetine
Serotonin Uptake Inhibitors

Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on July 02, 2009