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

August 24, 2005
November 21, 2012
June 2005
Not Provided
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Depressive Disorder, Major
  • Major Depressive Disorder (MDD)
Drug: GW679769
Other Name: GW679769
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
348
Not Provided
Not Provided

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).
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Belgium,   Chile,   Costa Rica,   Germany,   Italy,   Poland,   Slovakia,   Spain,   Sweden
 
NCT00413023
NKF100096
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2012

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