A Local Register Study For Major Depression Of Paroxetine Controlled Release

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00368303
First received: August 22, 2006
Last updated: May 31, 2012
Last verified: March 2011
  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
Depressive Disorder, Major
Major Depressive Disorder (MDD)
Drug: Paroxetine CR
Drug: Paroxetine IR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: 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

Resource links provided by NLM:


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
Intervention Details:
    Drug: Paroxetine CR Drug: Paroxetine IR
    Other Names:
    • Paroxetine IR
    • Paroxetine CR
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368303

Locations
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
China
GSK Investigational Site
Beijing, China, 100096
GSK Investigational Site
Beijing, China, 100083
GSK Investigational Site
Beijing, China, 100088
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00368303     History of Changes
Other Study ID Numbers: PCR103124
Study First Received: August 22, 2006
Last Updated: May 31, 2012
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental 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 July 20, 2014