A Study Of New Medicine (GSK 372475) For The Treatment Of Depression

October 2, 2014 updated by: GlaxoSmithKline

A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/Day to 2.0 mg/Day) or Extended Release Venlafaxine XR (150 mg/Day to 225 mg/Day) Compared to Placebo in Adult s

To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/day to 2.0 mg/day) or Extended Release Venlafaxine XR (150 mg/day to 225 mg/day) Compared to Placebo in Adult Subjects Diagnosed with Major Depressive Disorder

Study Type

Interventional

Enrollment (Actual)

396

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

  • Australia
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • GSK Investigational Site
      • Kippa Ring, Queensland, Australia, 4021
        • GSK Investigational Site
    • Victoria
      • Epping, Victoria, Australia, 3076
        • GSK Investigational Site
      • Heidelberg West, Victoria, Australia, 3081
        • GSK Investigational Site
  • Belgium
      • Liège, Belgium, 4000
        • GSK Investigational Site
      • Mont-Godinne, Belgium, 5530
        • GSK Investigational Site
  • Bulgaria
      • Burgas, Bulgaria, 8000
        • GSK Investigational Site
      • Varna, Bulgaria, 9010
        • GSK Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6L 5X8
        • GSK Investigational Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • GSK Investigational Site
    • Nova Scotia
      • Sydney, Nova Scotia, Canada, B1S 2E8
        • GSK Investigational Site
      • Sydney, Nova Scotia, Canada, B1P 1C6
        • GSK Investigational Site
    • Ontario
      • Burlington, Ontario, Canada, L7R 4E2
        • GSK Investigational Site
      • Mississauga, Ontario, Canada, L5M 4N4
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2T 2N6
        • GSK Investigational Site
  • Estonia
      • Tallinn, Estonia, 10614
        • GSK Investigational Site
      • Tartu, Estonia, 50417
        • GSK Investigational Site
      • Voru, Estonia, 65620
        • GSK Investigational Site
  • Finland
      • Kuopio, Finland, 70110
        • GSK Investigational Site
      • Turku, Finland, 20100
        • GSK Investigational Site
  • France
      • Arcachon, France, 33120
        • GSK Investigational Site
      • Paris, France, 75012
        • GSK Investigational Site
      • Toulouse, France, 31000
        • GSK Investigational Site
  • Germany
    • Bayern
      • Muenchen, Bayern, Germany, 80333
        • GSK Investigational Site
      • Unterhaching, Bayern, Germany, 82008
        • GSK Investigational Site
      • Wuerzburg, Bayern, Germany, 97070
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Germany, 19053
        • GSK Investigational Site
    • Niedersachsen
      • Westerstede, Niedersachsen, Germany, 26655
        • GSK Investigational Site
  • India
      • Bangalore, India, 560010
        • GSK Investigational Site
      • Chennai, India, 600003
        • GSK Investigational Site
      • Hyderabad, India, 500 034
        • GSK Investigational Site
      • Tirupati, India, 517507
        • GSK Investigational Site
  • Poland
      • Bialystok, Poland, 15-879
        • GSK Investigational Site
      • Gdansk, Poland, 80-282
        • GSK Investigational Site
      • Lublin, Poland, 20-442
        • GSK Investigational Site
      • Skorzewo, Poland, 60-185
        • GSK Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • GSK Investigational Site
      • Michalovce, Slovakia, 071 01
        • GSK Investigational Site
  • South Africa
      • Observatory ,Cape Town, South Africa, 7925
        • GSK Investigational Site
      • Somerset West, South Africa, 7140
        • GSK Investigational Site
      • Somerset West, South Africa, 7500
        • GSK Investigational Site
      • Vereeniging, South Africa, 1929
        • 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR criteria)
  • Duration of current episode is at least 12 weeks duration and less than 2 years
  • Symptoms of decreased energy, pleasure, and interest
  • Female subjects who agree to use acceptable methods of birth control throughout the study

Exclusion criteria:

  • Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial
  • Symptoms of MDE better accounted for by another diagnosis
  • Diagnosis of Bipolar, schizophrenia, other psychotic disorder(s), borderline or antisocial personality disorder, or dementia.
  • Started psychotherapy within 3 months prior to the Screening
  • Received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening
  • Received psychoactive drugs within 4 weeks of randomization
  • Positive urine drug screen or positive blood alcohol
  • Suicidal risk or has had any previous suicide attempt, a family history of suicide attempt
  • Positive pregnancy test
  • History of seizure disorder, myocardial infarction (< 1yr), or unstable medical condition
  • Failed to respond to an adequate course of pharmacotherapy of at least 2 different antidepressants

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
daily administration during the 10-week treatment phase
Experimental: GSK372475
flexible-dose design from GSK372475 1.0 mg/day to GSK372475 2.0 mg/day
Drug: GSK372475
daily administration during the 10-week treatment phase
Active Comparator: Venlafaxine
Flexible- dose design from Venlafaxine XR 75 mg/day to Venlafaxine XR 225 mg/day
Drug: venlafaxine
daily administration during the 10-week treatment phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale.
Time Frame: Randomisation (week 0) And end of the treatment
Randomisation (week 0) And end of the treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Endpoints related to response & remission on depression rating scales during time of treatment exposureChange during treatment & at endpoint-week 10:in Clinical Global Impression scale; in motivation, energy, & sexual functioning on patient-rated scales
Time Frame: Randomisation (week 0) and at weeks 1,2,4,6,8 and week 10 (end of treatment phase)
Randomisation (week 0) and at weeks 1,2,4,6,8 and week 10 (end of treatment phase)

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

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

April 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

March 13, 2007

First Submitted That Met QC Criteria

March 13, 2007

First Posted (Estimate)

March 15, 2007

Study Record Updates

Last Update Posted (Estimate)

October 10, 2014

Last Update Submitted That Met QC Criteria

October 2, 2014

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SND 103285

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.

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