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

October 26, 2016 updated by: GlaxoSmithKline

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).

Study Overview

Status

Completed

Conditions

Depressive Disorder, Major

Intervention / Treatment

Drug: GW679769

Study Type

Interventional

Enrollment (Actual)

348

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1122AAN
    - GSK Investigational Site
  - Ciudad Autonoma de Buenos Aires, Argentina, C1062ABF
    - GSK Investigational Site
  - Ciudad Autónoma de Buenos Aires, Argentina, C1425BPK
    - GSK Investigational Site
- Córdova
  - Cordoba, Córdova, Argentina, 5000
    - GSK Investigational Site
Belgium
- - Alken, Belgium, 3570
    - GSK Investigational Site
  - Kortrijk, Belgium, 8500
    - GSK Investigational Site
  - Liège, Belgium, 4000
    - GSK Investigational Site
  - Mont-Godinne, Belgium, 5530
    - GSK Investigational Site
Chile
- Región Metro De Santiago
  - Providencia / Santiago, Región Metro De Santiago, Chile, 7500710
    - GSK Investigational Site
  - Santiago, Región Metro De Santiago, Chile, 7580208
    - GSK Investigational Site
  - Santiago, Región Metro De Santiago, Chile
    - GSK Investigational Site
  - Santiago, Región Metro De Santiago, Chile, 7510186
    - GSK Investigational Site
Costa Rica
- - San José, Costa Rica
    - GSK Investigational Site
Germany
- - Berlin, Germany, 10629
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Ellwangen, Baden-Wuerttemberg, Germany, 73479
    - GSK Investigational Site
- Bayern
  - Wuerzburg, Bayern, Germany, 97070
    - GSK Investigational Site
- Hessen
  - Huettenberg, Hessen, Germany, 35625
    - GSK Investigational Site
- Niedersachsen
  - Achim, Niedersachsen, Germany, 28832
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Bochum, Nordrhein-Westfalen, Germany, 44869
    - GSK Investigational Site
  - Bochum, Nordrhein-Westfalen, Germany, 44892
    - GSK Investigational Site
  - Hattingen, Nordrhein-Westfalen, Germany, 45525
    - GSK Investigational Site
- Sachsen
  - Dresden, Sachsen, Germany, 01097
    - GSK Investigational Site
Italy
- Abruzzo
  - Guardiagrele (CH), Abruzzo, Italy, 66016
    - GSK Investigational Site
- Emilia-Romagna
  - Bologna, Emilia-Romagna, Italy, 40136
    - GSK Investigational Site
- Lombardia
  - Milano, Lombardia, Italy, 20127
    - GSK Investigational Site
- Toscana
  - Pisa, Toscana, Italy, 56126
    - GSK Investigational Site
Peru
- - Lima, Peru, Lima 27
    - GSK Investigational Site
Poland
- - Bialystok, Poland, 15-879
    - GSK Investigational Site
  - Chelmno, Poland, 86-200
    - GSK Investigational Site
  - Kościan, Poland, 64-000
    - GSK Investigational Site
Slovakia
- - Bratislava, Slovakia, 826 06
    - GSK Investigational Site
  - Bratislava, Slovakia, 813 69
    - GSK Investigational Site
  - Levoca, Slovakia, 054 01
    - GSK Investigational Site
  - Liptovsky Mikulas, Slovakia, 031 23
    - GSK Investigational Site
  - Rimavska Sobota, Slovakia, 979 12
    - GSK Investigational Site
  - Trencin, Slovakia, 911 01
    - GSK Investigational Site
Spain
- - Oviedo, Spain, 33011
    - GSK Investigational Site
Sweden
- - Solna, Sweden, SE-171 64
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in score on a Depression rating scale following 8 weeks of treatment.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

August 24, 2005

First Submitted That Met QC Criteria

December 18, 2006

First Posted (Estimate)

December 19, 2006

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NKF100096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

Study Protocol
Information identifier: NKF100096

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Information identifier: NKF100096

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: NKF100096

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan
Information identifier: NKF100096

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: NKF100096

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: NKF100096

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form
Information identifier: NKF100096

Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.