A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder
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
1 other identifier
interventional
372
0 countries
N/A
Brief Summary
A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2002
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2002
CompletedFirst Posted
Study publicly available on registry
October 30, 2002
CompletedStudy Start
First participant enrolled
November 4, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2003
CompletedOctober 9, 2017
October 1, 2017
11 months
October 28, 2002
October 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Depression Rating Scale
8 Weeks
Secondary Outcomes (1)
Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale
8 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- Patients meet the diagnosis of Major Depressive Disorder (MDD).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2002
First Posted
October 30, 2002
Study Start
November 4, 2002
Primary Completion
September 30, 2003
Study Completion
September 30, 2003
Last Updated
October 9, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.