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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00368303 |
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 |
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 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
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 |
Study Director: | GSK Clinical Trials, PhD | GlaxoSmithKline |
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 |
Major Depression paroxetine controlled release (CR) paroxetine immediate release (IR) |
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 |
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 |