search
Back to results

Major Depressive Disorder Study In Adults

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
paroxetine CR
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder Open-label discontinued

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient must have primary diagnosis of Major Depressive Disorder (MDD). Discontinued a selective serotonin reuptake inhibitor (SSRI)or serotonin-norepinephrine reuptake inhibitor (SNRI) regimen due to intolerability. Minimum time frame between last dose of previous antidepressant and initiation of study drug is one week. Maximum time frame between last dose of prior antidepressant and initiation of study drug is 2 months. Exclusion Criteria: Patient has previously been treated with the study drug. Is experiencing an adverse event attributed to previous SSRI/SNRI use that has not been resolved at least one week prior to Baseline Visit. Has a history of seizure disorder. Has met criteria for substance abuse or dependence within 6 months prior to Baseline Visit. Currently using an antidepressant. Currently pregnant.

Sites / Locations

  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center
  • GSK Clinical Trial Call Center

Outcomes

Primary Outcome Measures

The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events

Secondary Outcome Measures

Recurrence rates of adverse events causing intolerability of previous SSRI/SNRI, Adverse event incidence rates, Mean change from baseline in the Beck Depression Inventory-II total score, Proportion of responsers based on teh CGI Global Improvement Item

Full Information

First Posted
November 18, 2002
Last Updated
September 8, 2017
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00049972
Brief Title
Major Depressive Disorder Study In Adults
Official Title
An Open Label Study Assessing Paxil CR (Paroxetine CR) in Patients With Major Depressive Disorder Who Discontinued Treatment With Selective Serotonin Reuptake Inhibitors or a Selective Serotonin/Norepinephrine Reuptake Inhibitor Due to Intolerability
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
A study to obtain safety and tolerability data

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder Open-label discontinued

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
646 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
paroxetine CR
Primary Outcome Measure Information:
Title
The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events
Secondary Outcome Measure Information:
Title
Recurrence rates of adverse events causing intolerability of previous SSRI/SNRI, Adverse event incidence rates, Mean change from baseline in the Beck Depression Inventory-II total score, Proportion of responsers based on teh CGI Global Improvement Item

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must have primary diagnosis of Major Depressive Disorder (MDD). Discontinued a selective serotonin reuptake inhibitor (SSRI)or serotonin-norepinephrine reuptake inhibitor (SNRI) regimen due to intolerability. Minimum time frame between last dose of previous antidepressant and initiation of study drug is one week. Maximum time frame between last dose of prior antidepressant and initiation of study drug is 2 months. Exclusion Criteria: Patient has previously been treated with the study drug. Is experiencing an adverse event attributed to previous SSRI/SNRI use that has not been resolved at least one week prior to Baseline Visit. Has a history of seizure disorder. Has met criteria for substance abuse or dependence within 6 months prior to Baseline Visit. Currently using an antidepressant. Currently pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Chair
Facility Information:
Facility Name
GSK Clinical Trial Call Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
83704
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Fairfield
State/Province
Alabama
ZIP/Postal Code
35064
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36695
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72111
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Anaheim Hills
State/Province
California
ZIP/Postal Code
92807
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Clovis
State/Province
California
ZIP/Postal Code
93611
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Petaluma
State/Province
California
ZIP/Postal Code
94952
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19810
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32955
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
47905
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70127
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Prince Frederick
State/Province
Maryland
ZIP/Postal Code
20678
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Excelsior Springs
State/Province
Missouri
ZIP/Postal Code
64024
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89501
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Blackwood
State/Province
New Jersey
ZIP/Postal Code
08012
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Mercerville
State/Province
New Jersey
ZIP/Postal Code
08619
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Carrboro
State/Province
North Carolina
ZIP/Postal Code
27510
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Independence
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38134
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Selmer
State/Province
Tennessee
ZIP/Postal Code
38375
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Conroe
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
72505
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76137
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
West Valley City
State/Province
Utah
ZIP/Postal Code
84120
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Lebanon
State/Province
Virginia
ZIP/Postal Code
24266
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
GSK Clinical Trial Call Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Major Depressive Disorder Study In Adults

We'll reach out to this number within 24 hrs