A Local Register Study For Major Depression Of Paroxetine Controlled Release
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression
Intervention: Paroxetine CR (Drug); Paroxetine IR (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, PhD, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Scores on depression rating scale at treatment week 1,2,3,4,6 and 8.
Secondary outcome: Scores on clinical impression severity and improvement items at treatment week 1, 2,3,4,6,8
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Beijing 100083, China
GSK Clinical Trials Call Center, Beijing 100088, China
GSK Clinical Trials Call Center, Beijing 100096, China
GSK Clinical Trials Call Center, Changsha 410011, China
GSK Clinical Trials Call Center, Guangzhou 510370, China
GSK Clinical Trials Call Center, Chengdu 610041, China
GSK Clinical Trials Call Center, Xi'an 710061, China
GSK Clinical Trials Call Center, Nanjing 210029, China
GSK Clinical Trials Call Center, Xi'an 710032, China
GSK Clinical Trials Call Center, Kunming 650032, China
GSK Clinical Trials Call Center, Baoding 071000, China
Additional Information
Starting date: September 2006
Last updated: December 4, 2007
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