Back to resultsA Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
GW597599B
paroxetine
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depression, Psychiatry, Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria: Patients meet the diagnosis of Major Depressive Disorder (MDD). Exclusion Criteria: Patients with a primary diagnosis other than MDD. Patients with a history of schizophrenia, schizoaffective disorders, seizure disorders or bipolar affective disorder. Patients receiving formal psychotherapy or cognitive/behavioral therapy concurrently or in the 12 weeks prior to screening visit. Patient is actively suicidal. Patients who have a history of migraine headaches.
Sites / Locations
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale
Secondary Outcome Measures
Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00048204
Brief Title
A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder
Official Title
An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Fixed-Dose Study Comparing the Efficacy and Safety of GW597599B or Paroxetine to Placebo in Moderately to Severely Depressed Patients With Major Depressive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 4, 2002 (Actual)
Primary Completion Date
September 30, 2003 (Actual)
Study Completion Date
September 30, 2003 (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
A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Depression, Psychiatry, Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
372 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GW597599B
Intervention Type
Drug
Intervention Name(s)
paroxetine
Other Intervention Name(s)
GW597599B
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale
Time Frame
8 Weeks
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 meet the diagnosis of Major Depressive Disorder (MDD).
Exclusion Criteria:
Patients with a primary diagnosis other than MDD.
Patients with a history of schizophrenia, schizoaffective disorders, seizure disorders or bipolar affective disorder.
Patients receiving formal psychotherapy or cognitive/behavioral therapy concurrently or in the 12 weeks prior to screening visit.
Patient is actively suicidal.
Patients who have a history of migraine headaches.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKD20006
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKD20006
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKD20006
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKD20006
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKD20006
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKD20006
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
NKD20006
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder
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