| August 22, 2006 |
| May 15, 2009 |
| December 2006 |
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| Scores on depression rating scale at treatment week 1,2,3,4,6 and 8. |
| Scores on depression rating scale at treatment week 1,2,3,4,6 and 8. |
| Complete list of historical versions of study NCT00368303 on ClinicalTrials.gov Archive Site |
| Scores on clinical impression severity and improvement items at treatment week 1, 2,3,4,6,8 |
| Scores on clinical impression severity and improvement items at treatment week 1, 2,3,4,6,8 |
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| A Local Register Study For Major Depression Of Paroxetine Controlled Release |
| 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 |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
| Major Depressive Disorder (MDD) |
- Drug: Paroxetine CR
- Drug: Paroxetine IR
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| |
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| Completed |
| 362 |
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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.
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| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| China |
| |
| NCT00368303 |
| Study Director, GSK |
| PCR103124 |
| GlaxoSmithKline |
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| Study Director: |
GSK Clinical Trials, PhD |
GlaxoSmithKline |
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| GlaxoSmithKline |
| May 2009 |