Clinical trial NCT00368303: A Local Register Study For Major Depression Of Paroxetine Controlled Release
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Major Depressive Disorder (MDD)
Keywords: Major Depression
paroxetine controlled release (CR)
paroxetine immediate release (IR)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-24
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Depression.


Eligibility 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.

Primary outcomes:
measure: Scores on depression rating scale at treatment week 1,2,3,4,6 and 8.
Secondary outcomes:
measure: Scores on clinical impression severity and improvement items at treatment week 1, 2,3,4,6,8
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: GSK Investigational Site
state: Guangdong
city: Baoding
country: China
facility: GSK Investigational Site
state: Hebei
city: Changsha
country: China
facility: GSK Investigational Site
state: Hunan
city: Nanjing
country: China
facility: GSK Investigational Site
state: Jiangsu
city: Xi'an
country: China
facility: GSK Investigational Site
state: Shaanxi
city: Xi'an
country: China
facility: GSK Investigational Site
state: Shaanxi
city: Chengdu
country: China
facility: GSK Investigational Site
state: Sichuan
city: Kunming
country: China
facility: GSK Investigational Site
state: Yunnan
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: