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CompletedNCT00368303Updated Jun 4, 2012

A Local Register Study For Major Depression Of Paroxetine Controlled Release

A Phase 3 interventional study of Paroxetine CR and Paroxetine IR in Depressive Disorder, Major and Major Depressive Disorder (MDD), sponsored by GlaxoSmithKline. Completed at 11 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-06-04.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
362
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Major Depression
  • paroxetine controlled release (CR)
  • paroxetine immediate release (IR)
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 362 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
362 participants

Interventions

  • DrugParoxetine CR
  • DrugParoxetine IR

    Also known as: Paroxetine CR

06

What researchers measure

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

07

Study locations

11 sites
  • GSK Investigational Site
    Guangzhou, Guangdong 510370, China
  • GSK Investigational Site
    Baoding, Hebei 071000, China
  • GSK Investigational Site
    Changsha, Hunan 410011, China
  • GSK Investigational Site
    Nanjing, Jiangsu 210029, China
  • GSK Investigational Site
    Xi'an, Shaanxi 710032, China
  • GSK Investigational Site
    Xi'an, Shaanxi 710061, China
  • GSK Investigational Site
    Chengdu, Sichuan 610041, China
  • GSK Investigational Site
    Kunming, Yunnan 650032, China
  • GSK Investigational Site
    Beijing, 100083, China
  • GSK Investigational Site
    Beijing, 100088, China
  • GSK Investigational Site
    Beijing, 100096, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00368303
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Aug 24, 2006
Start date
Dec 2006
Last update
Jun 4, 2012

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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