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A Local Register Study For Major Depression Of Paroxetine Controlled Release
This study has been completed.
First Received: August 22, 2006   Last Updated: October 15, 2008   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00368303
  Purpose

The study is to investigate the non-inferior efficacy of Paroxetine Controlled Release to Paroxetine Immediate Release, as well as the drug tolerability profile when treated on patients with Major Depression.


Condition Intervention Phase
Major Depressive Disorder (MDD)
Drug: Paroxetine IR
Drug: Paroxetine CR
Phase III

MedlinePlus related topics: Depression
Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Double-Blind, Parallel Assignment, Randomized, Safety/Efficacy Study, Treatment
Official Title: A Multicentre, Double-Blind, Active Controlled Trial to Evaluate the Clinical Effects of Immediate Release Paroxetine and Controlled Release Paroxetine in the Treatment of Major Depression

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Scores on depression rating scale at treatment week 1,2,3,4,6 and 8.

Secondary Outcome Measures:
  • Scores on clinical impression severity and improvement items at treatment week 1, 2,3,4,6,8

Estimated Enrollment: 362
Study Start Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with Major Depressive Disorder,score on depression rating scale reach a specific point(17 item Hamilton Depression Scale>18).

Exclusion criteria:

  • patients use monoamine oxidase inhibitors (MAOIs), benzodiazepines, Chinese herbal medicines, acupuncture, moxibustion or other psychoactive medications other than zolpidem, zopiclone;diagnosed with other Axis I disorder other; not responsive to paroxetine therapy before; pregnant or lactating, have serious medical disorder or condition that would preclude the administration of paroxetine; have a history of seizure disorders (except for febrile seizures in childhood); require treatment with warfarin anticoagulants, phenytoin, cimetidine, sumatriptan, type 1C antiarrhythmics, quinidine or sulfonylurea derivatives; are substance abuse or dependence (alcohol or drugs) within 6 months prior to this trial; have had electroconvulsive therapy within 2 months of entry into the study; pose a current, serious suicidal or homicidal risk; have taken other psychotropic drugs or antidepressants other than MAO inhibitors within 7 days of baseline and MAO inhibitors within 14 days of baseline; have taken any investigational drug, or participated in a clinical trial within the past 3 months; are hypersensitivity to paroxetine; have undergoing formal psychotherapy/psychoanalysis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00368303

Locations
China
GSK Investigational Site
Beijing, China, 100096
GSK Investigational Site
Beijing, China, 100083
GSK Investigational Site
Beijing, China, 100088
China, Guangdong
GSK Investigational Site
Guangzhou, Guangdong, China, 510370
China, Hebei
GSK Investigational Site
Baoding, Hebei, China, 071000
China, Hunan
GSK Investigational Site
Changsha, Hunan, China, 410011
China, Jiangsu
GSK Investigational Site
Nanjing, Jiangsu, China, 210029
China, Shaanxi
GSK Investigational Site
Xi'an, Shaanxi, China, 710032
GSK Investigational Site
Xi'an, Shaanxi, China, 710061
China, Sichuan
GSK Investigational Site
Chengdu, Sichuan, China, 610041
China, Yunnan
GSK Investigational Site
Kunming, Yunnan, China, 650032
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, PhD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: PCR103124
Study First Received: August 22, 2006
Last Updated: October 15, 2008
ClinicalTrials.gov Identifier: NCT00368303     History of Changes
Health Authority: China: State Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Major Depression
paroxetine controlled release (CR)
paroxetine immediate release (IR)

Study placed in the following topic categories:
Neurotransmitter Agents
Depression
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Paroxetine
Serotonin Uptake Inhibitors
Serotonin
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:
Paroxetine
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
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 March 13, 2009