search
Back to results

A Local Register Study For Major Depression Of Paroxetine Controlled Release

Primary Purpose

Depressive Disorder, Major, Major Depressive Disorder (MDD)

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Paroxetine CR
Paroxetine IR
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Major Depression, paroxetine controlled release (CR), paroxetine immediate release (IR)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

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

Full Information

First Posted
August 22, 2006
Last Updated
May 31, 2012
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00368303
Brief Title
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

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major, Major Depressive Disorder (MDD)
Keywords
Major Depression, paroxetine controlled release (CR), paroxetine immediate release (IR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
362 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Paroxetine CR
Intervention Type
Drug
Intervention Name(s)
Paroxetine IR
Other Intervention Name(s)
Paroxetine CR
Primary Outcome Measure Information:
Title
Scores on depression rating scale at treatment week 1,2,3,4,6 and 8.
Secondary Outcome Measure Information:
Title
Scores on clinical impression severity and improvement items at treatment week 1, 2,3,4,6,8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510370
Country
China
Facility Name
GSK Investigational Site
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071000
Country
China
Facility Name
GSK Investigational Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
GSK Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
GSK Investigational Site
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Name
GSK Investigational Site
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
GSK Investigational Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
GSK Investigational Site
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100088
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100096
Country
China

12. IPD Sharing Statement

Learn more about this trial

A Local Register Study For Major Depression Of Paroxetine Controlled Release

We'll reach out to this number within 24 hrs