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

Depressive Disorder, Major Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413023
• Other study ID #: NKF100096
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2005
• Last updated: October 26, 2016
• Start date: June 2005
• Est. completion date: September 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease

Intervention

Drug:
• GW679769

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	GSK Investigational Site	Cordoba	Córdova
Belgium	GSK Investigational Site	Alken
Belgium	GSK Investigational Site	Kortrijk
Belgium	GSK Investigational Site	Liège
Belgium	GSK Investigational Site	Mont-Godinne
Chile	GSK Investigational Site	Providencia / Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Costa Rica	GSK Investigational Site	San José
Germany	GSK Investigational Site	Achim	Niedersachsen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Ellwangen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Hattingen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Huettenberg	Hessen
Germany	GSK Investigational Site	Wuerzburg	Bayern
Italy	GSK Investigational Site	Bologna	Emilia-Romagna
Italy	GSK Investigational Site	Guardiagrele (CH)	Abruzzo
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Pisa	Toscana
Peru	GSK Investigational Site	Lima
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Chelmno
Poland	GSK Investigational Site	Koscian
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Levoca
Slovakia	GSK Investigational Site	Liptovsky Mikulas
Slovakia	GSK Investigational Site	Rimavska Sobota
Slovakia	GSK Investigational Site	Trencin
Spain	GSK Investigational Site	Oviedo
Sweden	GSK Investigational Site	Solna

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Argentina,  Belgium,  Chile,  Costa Rica,  Germany,  Italy,  Peru,  Poland,  Slovakia,  Spain,  Sweden, 

References & 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. Erratum in: J Clin Psychopharmacol. 2012 Apr;32(2):185. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in score on a Depression rating scale following 8 weeks of treatment.
Secondary	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.

External Links

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