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Study Of GW679769 In Major Depressive Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00102492
First Posted: January 31, 2005
Last Update Posted: April 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
This is a placebo-controlled, fixed dose study that will evaluate the efficacy and safety of GW679769 in subjects with major depressive disorder.

Condition Intervention Phase
Depressive Disorder, Major Major Depressive Disorder (MDD) Drug: GW679769 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study Evaluating the Efficacy and Safety of GW679769 in Subjects With Major Depressive Disorder.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline on the 17-item Hamilton Depression Rating Scale (HAM-D) total score at week 8, Last Observation Carried Forward.

Secondary Outcome Measures:
  • CGI, HAM-A, QUIDS, SDS, MOS-12 Sleep Module, LSEQ, Safety and Tolerability, PK/PD

Enrollment: 356
Study Start Date: October 2004
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Subjects must have the ability to comprehend the key components of the consent form.
  • Subject must have met DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria for current MDE (major depressive episode) for at least 8 weeks prior to the Screening Visit.
  • If female, subjects must be practicing an acceptable method of birth control.
  • Subjects must have rating scores as outlined.

Exclusion criteria:

  • Subjects whose symptoms of the MDE are better accounted for by another diagnosis.
  • Subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder.
  • Subjects have a positive urine test for illicit drug use and/or a history of substance abuse or alcohol dependence within the past 12 months.
  • Subjects with an unstable medical disorder.
  • If female, pregnant or lactating.
  • Subjects who have received ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation) within the 6 months preceding screening or who have ever been homicidal.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102492


  Show 31 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00102492     History of Changes
Other Study ID Numbers: NKF100092
First Submitted: January 29, 2005
First Posted: January 31, 2005
Last Update Posted: April 16, 2015
Last Verified: April 2015

Keywords provided by GlaxoSmithKline:
Major Depressive Disorder
Major Depression
Mood Disorders
Major Depressive Episode

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Casopitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action