Status:
COMPLETED
A Local Register Study For Major Depression Of Paroxetine Controlled Release
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder, Major
Major Depressive Disorder (MDD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 Dep...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT00368303
Start Date
December 1 2006
Last Update
June 4 2012
Active Locations (11)
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1
GSK Investigational Site
Guangzhou, Guangdong, China, 510370
2
GSK Investigational Site
Baoding, Hebei, China, 071000
3
GSK Investigational Site
Changsha, Hunan, China, 410011
4
GSK Investigational Site
Nanjing, Jiangsu, China, 210029