A Randomised, Double-Blind, Double-Dummy, Parallel-Group,... | EligiMed

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)

CompletadoFase 2ClinicalTrials.gov

ID: NCT00413023Tipo: INTERVENTIONALInicio: 1 de jun de 2005Fin estimado: 1 de sept de 2006

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 64 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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).

Intervenciones

drug

GW679769

Ubicaciones

GSK Investigational Site

Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Córdoba, Córdoba Province, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalGlaxoSmithKline

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