A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: October 28, 2002
Last updated: February 11, 2013
Last verified: February 2013
A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD)

Condition Intervention Phase
Major Depressive Disorder
Drug: GW597599B
Drug: paroxetine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: 8 Weeks ]

Secondary Outcome Measures:
  • Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale [ Time Frame: 8 Weeks ]

Enrollment: 372
Study Start Date: November 2002
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00048204

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Sponsors and Collaborators
Study Director: GSK Clinical Trial, MD, MPH GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00048204     History of Changes
Other Study ID Numbers: NKD20006 
Study First Received: October 28, 2002
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by GlaxoSmithKline:
Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2016