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

NCT ID: NCT00413023

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

348 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-09-30

Brief Summary

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

Detailed Description

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Conditions

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Depressive Disorder, Major

Keywords

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depression major depressive disorder MDD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW679769

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Buenos Aires, Buenos Aires, Argentina

Site Status

GSK Investigational Site

Córdoba, Córdoba Province, Argentina

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GSK Investigational Site

Buenos Aires, , Argentina

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GSK Investigational Site

Buenos Aires, , Argentina

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GSK Investigational Site

Alken, , Belgium

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GSK Investigational Site

Kortrijk, , Belgium

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GSK Investigational Site

Liège, , Belgium

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GSK Investigational Site

Mont-Godinne, , Belgium

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GSK Investigational Site

Providencia / Santiago, Región Metro de Santiago, Chile

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GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

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GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

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GSK Investigational Site

San José, Provincia de San José, Costa Rica

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GSK Investigational Site

San José, , Costa Rica

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GSK Investigational Site

Ellwangen, Baden-Wurttemberg, Germany

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GSK Investigational Site

Würzburg, Bavaria, Germany

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GSK Investigational Site

Hüttenberg, Hesse, Germany

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GSK Investigational Site

Achim, Lower Saxony, Germany

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GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

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GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

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GSK Investigational Site

Hattingen, North Rhine-Westphalia, Germany

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GSK Investigational Site

Dresden, Saxony, Germany

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GSK Investigational Site

Berlin, State of Berlin, Germany

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GSK Investigational Site

Guardiagrele (CH), Abruzzo, Italy

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GSK Investigational Site

Bologna, Emilia-Romagna, Italy

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GSK Investigational Site

Milan, Lombardy, Italy

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GSK Investigational Site

Pisa, Tuscany, Italy

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GSK Investigational Site

Lima, , Peru

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GSK Investigational Site

Bialystok, , Poland

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GSK Investigational Site

Chełmno, , Poland

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GSK Investigational Site

Kościan, , Poland

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GSK Investigational Site

Bratislava, , Slovakia

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GSK Investigational Site

Bratislava, , Slovakia

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GSK Investigational Site

Levoča, , Slovakia

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GSK Investigational Site

Liptovský Mikuláš, , Slovakia

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GSK Investigational Site

Rimavská Sobota, , Slovakia

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GSK Investigational Site

Trenčín, , Slovakia

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GSK Investigational Site

Oviedo, , Spain

Site Status

GSK Investigational Site

Solna, , Sweden

Site Status

Countries

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

References

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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.

Reference Type BACKGROUND
PMID: 22020354 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Dataset Specification

View Document

Document Type: Clinical Study Report

View Document

Document Type: Annotated Case Report Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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NKF100096

Identifier Type: -

Identifier Source: org_study_id