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| Sponsor: | 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 CR Drug: Paroxetine IR |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contacts and 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 | |
| Study Director: | GSK Clinical Trials, PhD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | PCR103124 |
| Study First Received: | August 22, 2006 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00368303 History of Changes |
| Health Authority: | China: State Food and Drug Administration |
|
paroxetine immediate release (IR) paroxetine controlled release (CR) Major Depression |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Depression Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder, Major 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 |