Study Of The Effects Of A New Antidepressant Therapy In Patients With Major Depressive Disorder (MDD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00413023
First received: August 24, 2005
Last updated: November 21, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to assess the efficacy, safety and tolerability of GW679769 patients with Major depressive Disorder (MDD).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects With Major Depressive Disorder (MDD)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in score on a Depression rating scale following 8 weeks of treatment.

Secondary Outcome Measures:
  • Change in score on a number of rating scales following 8 weeks of treatment assessing symptomatic, behavioural and functional parameters which together provide a more complete description of the disorder.

Estimated Enrollment: 348
Study Start Date: June 2005
Intervention Details:
    Drug: GW679769
    Other Name: GW679769
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Primary diagnosis of Major depressive Disorder as defined in DSM-IV.
  • Capable of giving informed consent and willing to comply with the study requirements.
  • Women of childbearing potential must agree to one of a number of defined acceptable methods of birth control.

Exclusion Criteria:

  • Primary diagnosis within the past 6 months of another Axis 1 disorder such as an anxiety disorder.
  • Use of medications for a psychiatric condition including herbals in the past 2-12 weeks according to medication type.
  • Subjects who, in the investigator's judgement, pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months.
  • Subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine).
  • Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413023

  Hide Study Locations
Locations
Argentina
GSK Investigational Site
Cordoba, Córdova, Argentina, 5000
GSK Investigational Site
Buenos Aires, Argentina, C1122AAN
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1062ABF
Belgium
GSK Investigational Site
Alken, Belgium, 3570
GSK Investigational Site
Kortrijk, Belgium, 8500
GSK Investigational Site
Liège, Belgium, 4000
GSK Investigational Site
Mont-Godinne, Belgium, 5530
Chile
GSK Investigational Site
Providencia / Santiago, Región Metro De Santiago, Chile, 7500710
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7510186
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7580208
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
Costa Rica
GSK Investigational Site
San José, Costa Rica
Germany
GSK Investigational Site
Ellwangen, Baden-Wuerttemberg, Germany, 73479
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Huettenberg, Hessen, Germany, 35625
GSK Investigational Site
Achim, Niedersachsen, Germany, 28832
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44892
GSK Investigational Site
Hattingen, Nordrhein-Westfalen, Germany, 45525
GSK Investigational Site
Dresden, Sachsen, Germany, 01097
GSK Investigational Site
Berlin, Germany, 10629
Italy
GSK Investigational Site
Guardiagrele (CH), Abruzzo, Italy, 66016
GSK Investigational Site
Bologna, Emilia-Romagna, Italy, 40136
GSK Investigational Site
Milano, Lombardia, Italy, 20127
GSK Investigational Site
Pisa, Toscana, Italy, 56126
Poland
GSK Investigational Site
Bialystok, Poland, 15-879
GSK Investigational Site
Kościan, Poland, 64-000
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 826 06
GSK Investigational Site
Bratislava, Slovakia, 813 69
GSK Investigational Site
Liptovsky Mikulas, Slovakia, 031 23
GSK Investigational Site
Rimavska Sobota, Slovakia, 979 12
GSK Investigational Site
Trencin, Slovakia, 911 01
Spain
GSK Investigational Site
Oviedo, Spain, 33011
Sweden
GSK Investigational Site
Solna, Sweden, SE-171 64
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00413023     History of Changes
Other Study ID Numbers: NKF100096
Study First Received: August 24, 2005
Last Updated: November 21, 2012
Health Authority: Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Keywords provided by GlaxoSmithKline:
depression
major depressive disorder
MDD

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

ClinicalTrials.gov processed this record on September 18, 2014