A Local Register Study For Major Depression Of Paroxetine Controlled Release
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00368303
First received: August 22, 2006
Last updated: May 31, 2012
Last verified: March 2011
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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:
MedlinePlus related topics:
Depression
Drug Information available for:
Paroxetine
Paroxetine hydrochloride
Paroxetine hydrochloride hemihydrate
Paroxetine Mesylate
U.S. FDA Resources
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
- Paroxetine IR
- Paroxetine CR
Other Names:
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, 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 May 16, 2013