A Local Register Study For Major Depression Of Paroxetine Controlled Release

NCT00368303 | Completed Phase 3

• 1 other identifier: PCR103124
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 11

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.

Conditions

Depressive Disorder, Major; Major Depressive Disorder (MDD)

Keywords

Major Depression; paroxetine controlled release (CR); paroxetine immediate release (IR)

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Paroxetine CR DRUG

Paroxetine IR DRUG

Also known as: Paroxetine CR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Major Depressive Disorder,score on depression rating scale reach a specific point(17 item Hamilton Depression Scale\>18).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (11)

GSK Investigational Site

Guangzhou, Guangdong, 510370, China

Location

GSK Investigational Site

Baoding, Hebei, 071000, China

Location

GSK Investigational Site

Changsha, Hunan, 410011, China

Location

GSK Investigational Site

Nanjing, Jiangsu, 210029, China

Location

GSK Investigational Site

Xi'an, Shaanxi, 710032, China

Location

GSK Investigational Site

Xi'an, Shaanxi, 710061, China

Location

GSK Investigational Site

Chengdu, Sichuan, 610041, China

Location

GSK Investigational Site

Kunming, Yunnan, 650032, China

Location

GSK Investigational Site

Beijing, 100083, China

Location

GSK Investigational Site

Beijing, 100088, China

Location

GSK Investigational Site

Beijing, 100096, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2006
• First Posted: August 24, 2006
• Study Start: December 1, 2006
• Last Updated: June 4, 2012

Record last verified: 2011-03

Locations

CN (11)