A Local Register Study For Major Depression Of Paroxetine Controlled Release

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00368303

Collaborator

(none)

362

Enrollment

Locations

32.9

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder, Major Major Depressive Disorder (MDD)	Drug: Paroxetine CR Drug: Paroxetine IR	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

Scores on depression rating scale at treatment week 1,2,3,4,6 and 8. []

Secondary Outcome Measures

Scores on clinical impression severity and improvement items at treatment week 1, 2,3,4,6,8 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	GSK Investigational Site	Xi'an	Shaanxi	China	710032
6	GSK Investigational Site	Xi'an	Shaanxi	China	710061
7	GSK Investigational Site	Chengdu	Sichuan	China	610041
8	GSK Investigational Site	Kunming	Yunnan	China	650032
9	GSK Investigational Site	Beijing		China	100083
10	GSK Investigational Site	Beijing		China	100088
11	GSK Investigational Site	Beijing		China	100096