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Clinical Trials/NCT00048204
NCT00048204
Completed
Phase 2

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

GlaxoSmithKline0 sites372 target enrollmentNovember 4, 2002

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Depressive Disorder, Major
Sponsor
GlaxoSmithKline
Enrollment
372
Primary Endpoint
Hamilton Depression Rating Scale
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD)

Registry
clinicaltrials.gov
Start Date
November 4, 2002
End Date
September 30, 2003
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale

Time Frame: 8 Weeks

Secondary Outcomes

  • Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale(8 Weeks)

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