NCT Number: NCT00368303
A Local Register Study For Major Depression Of Paroxetine Controlled Release
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
GSK Investigational Site, Guangzhou, Guangdong, China
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Paroxetine IR
DrugOther names: Paroxetine CR
Primary outcomes
-
Scores on depression rating scale at treatment week 1,2,3,4,6 and 8.
Secondary outcomes
-
Scores on clinical impression severity and improvement items at treatment week 1, 2,3,4,6,8
Sponsors and collaborators
Lead sponsor
GlaxoSmithKline
Industry
Registry information
Official study 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
Important dates
- Study start
- 2006
- First posted
- Aug 24, 2006
- Registry last updated
- Jun 4, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Sexual Functioning Study With Antidepressants
NCT00316160
Behavior, Behavioral Symptoms
Mesa, Arizona, United States
View Trial DetailsDepression Study In Elderly Patients
NCT00067444
Depressive Disorder, Depressive Disorder, Major
Little Rock, Arkansas, United States
View Trial DetailsStudy Of GW679769 In Major Depressive Disorder
NCT00102492
Depressive Disorder, Depressive Disorder, Major
Scottsdale, Arizona, United States
View Trial DetailsPatient Tolerability Study of GSK163090
NCT00559299
Behavior, Behavioral Symptoms
Wichita, Kansas, United States
View Trial Details