A Local Register Study For Major Depression Of Paroxetine Controlled Release

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368303
• Other study ID #: PCR103124
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2006
• Last updated: May 31, 2012
• Start date: December 2006

Study information

• Verified date: March 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder (MDD)

Intervention

Drug:
• Paroxetine CR

• Paroxetine IR

Locations

Country	Name	City	State
China	GSK Investigational Site	Baoding	Hebei
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Changsha	Hunan
China	GSK Investigational Site	Chengdu	Sichuan
China	GSK Investigational Site	Guangzhou	Guangdong
China	GSK Investigational Site	Kunming	Yunnan
China	GSK Investigational Site	Nanjing	Jiangsu
China	GSK Investigational Site	Xi'an	Shaanxi
China	GSK Investigational Site	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on depression rating scale at treatment week 1,2,3,4,6 and 8.
Secondary	Scores on clinical impression severity and improvement items at treatment week 1, 2,3,4,6,8