We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00413023
First Posted: December 19, 2006
Last Update Posted: October 28, 2016
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
August 24, 2005
December 19, 2006
October 28, 2016
June 2005
September 2006   (Final data collection date for primary outcome measure)
Change in score on a Depression rating scale following 8 weeks of treatment.
Same as current
Complete list of historical versions of study NCT00413023 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Study Of The Effects Of A New Antidepressant Therapy In Patients With Major Depressive Disorder (MDD)
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)
The purpose of this study is to assess the efficacy, safety and tolerability of GW679769 patients with Major depressive Disorder (MDD).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Depressive Disorder, Major
Drug: GW679769
Not Provided
Ratti E, Bellew K, Bettica P, Bryson H, Zamuner S, Archer G, Squassante L, Bye A, Trist D, Krishnan KR, Fernandes S. Results from 2 randomized, double-blind, placebo-controlled studies of the novel NK1 receptor antagonist casopitant in patients with major depressive disorder. J Clin Psychopharmacol. 2011 Dec;31(6):727-33. doi: 10.1097/JCP.0b013e31823608ca. Erratum in: J Clin Psychopharmacol. 2012 Apr;32(2):185.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
348
September 2006
September 2006   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Belgium,   Chile,   Costa Rica,   Germany,   Italy,   Peru,   Poland,   Slovakia,   Spain,   Sweden
Croatia,   France
 
NCT00413023
NKF100096
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP