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)
1 other identifier
interventional
348
11 countries
39
Brief Summary
The purpose of this study is to assess the efficacy, safety and tolerability of GW679769 patients with Major depressive Disorder (MDD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2005
Shorter than P25 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 24, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFirst Posted
Study publicly available on registry
December 19, 2006
CompletedOctober 28, 2016
October 1, 2016
1.3 years
August 24, 2005
October 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in score on a Depression rating scale following 8 weeks of treatment.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (39)
GSK Investigational Site
Buenos Aires, Buenos Aires, C1122AAN, Argentina
GSK Investigational Site
Córdoba, Córdoba Province, 5000, Argentina
GSK Investigational Site
Buenos Aires, C1062ABF, Argentina
GSK Investigational Site
Buenos Aires, C1425BPK, Argentina
GSK Investigational Site
Alken, 3570, Belgium
GSK Investigational Site
Kortrijk, 8500, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Mont-Godinne, 5530, Belgium
GSK Investigational Site
Providencia / Santiago, Región Metro de Santiago, 7500710, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7510186, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7580208, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile
GSK Investigational Site
San José, Provincia de San José, Costa Rica
GSK Investigational Site
San José, Costa Rica
GSK Investigational Site
Ellwangen, Baden-Wurttemberg, 73479, Germany
GSK Investigational Site
Würzburg, Bavaria, 97070, Germany
GSK Investigational Site
Hüttenberg, Hesse, 35625, Germany
GSK Investigational Site
Achim, Lower Saxony, 28832, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44869, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44892, Germany
GSK Investigational Site
Hattingen, North Rhine-Westphalia, 45525, Germany
GSK Investigational Site
Dresden, Saxony, 01097, Germany
GSK Investigational Site
Berlin, State of Berlin, 10629, Germany
GSK Investigational Site
Guardiagrele (CH), Abruzzo, 66016, Italy
GSK Investigational Site
Bologna, Emilia-Romagna, 40136, Italy
GSK Investigational Site
Milan, Lombardy, 20127, Italy
GSK Investigational Site
Pisa, Tuscany, 56126, Italy
GSK Investigational Site
Lima, Lima 27, Peru
GSK Investigational Site
Bialystok, 15-879, Poland
GSK Investigational Site
Chełmno, 86-200, Poland
GSK Investigational Site
Kościan, 64-000, Poland
GSK Investigational Site
Bratislava, 813 69, Slovakia
GSK Investigational Site
Bratislava, 826 06, Slovakia
GSK Investigational Site
Levoča, 054 01, Slovakia
GSK Investigational Site
Liptovský Mikuláš, 031 23, Slovakia
GSK Investigational Site
Rimavská Sobota, 979 12, Slovakia
GSK Investigational Site
Trenčín, 911 01, Slovakia
GSK Investigational Site
Oviedo, 33011, Spain
GSK Investigational Site
Solna, SE-171 64, Sweden
Related Publications (1)
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.
PMID: 22020354BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2005
First Posted
December 19, 2006
Study Start
June 1, 2005
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
October 28, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.