A Study Of New Medicine (GSK 372475) For The Treatment Of Depression
NCT ID: NCT00448058
Last Updated: 2014-10-10
Study Results
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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COMPLETED
PHASE2
396 participants
INTERVENTIONAL
2007-04-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GSK372475
flexible-dose design from GSK372475 1.0 mg/day to GSK372475 2.0 mg/day
GSK372475
daily administration during the 10-week treatment phase
Venlafaxine
Flexible- dose design from Venlafaxine XR 75 mg/day to Venlafaxine XR 225 mg/day
venlafaxine
daily administration during the 10-week treatment phase
placebo
placebo
daily administration during the 10-week treatment phase
Interventions
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GSK372475
daily administration during the 10-week treatment phase
venlafaxine
daily administration during the 10-week treatment phase
placebo
daily administration during the 10-week treatment phase
Eligibility Criteria
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Inclusion 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
* 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
18 Years
64 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Auchenflower, Queensland, Australia
GSK Investigational Site
Kippa-Ring, Queensland, Australia
GSK Investigational Site
Epping, Victoria, Australia
GSK Investigational Site
Heidelberg West, Victoria, Australia
GSK Investigational Site
Liège, , Belgium
GSK Investigational Site
Mont-Godinne, , Belgium
GSK Investigational Site
Burgas, , Bulgaria
GSK Investigational Site
Varna, , Bulgaria
GSK Investigational Site
Edmonton, Alberta, Canada
GSK Investigational Site
Kelowna, British Columbia, Canada
GSK Investigational Site
Sydney, Nova Scotia, Canada
GSK Investigational Site
Sydney, Nova Scotia, Canada
GSK Investigational Site
Burlington, Ontario, Canada
GSK Investigational Site
Mississauga, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Tallinn, , Estonia
GSK Investigational Site
Tartu, , Estonia
GSK Investigational Site
Võru, , Estonia
GSK Investigational Site
Kuopio, , Finland
GSK Investigational Site
Turku, , Finland
GSK Investigational Site
Arcachon, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Toulouse, , France
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Unterhaching, Bavaria, Germany
GSK Investigational Site
Würzburg, Bavaria, Germany
GSK Investigational Site
Westerstede, Lower Saxony, Germany
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany
GSK Investigational Site
Bangalore, , India
GSK Investigational Site
Chennai, , India
GSK Investigational Site
Hyderabad, , India
GSK Investigational Site
Tirupati, , India
GSK Investigational Site
Bialystok, , Poland
GSK Investigational Site
Gdansk, , Poland
GSK Investigational Site
Lublin, , Poland
GSK Investigational Site
Skorzewo, , Poland
GSK Investigational Site
Bratislava, , Slovakia
GSK Investigational Site
Michalovce, , Slovakia
GSK Investigational Site
Observatory ,Cape Town, , South Africa
GSK Investigational Site
Somerset West, , South Africa
GSK Investigational Site
Somerset West, , South Africa
GSK Investigational Site
Vereeniging, , South Africa
Countries
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References
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Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell J, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Results of Two Double-Blind, Placebo- and Active-Controlled Studies of GSK372475, a Triple Monoamine Reuptake Inhibitor, in the Treatment of Major Depressive Disorder. [J Psychopharmacol EPublication ahead of print. DOI 10.1177/0269881111424931]. 2011;
Learned S, Graff O, Roychowdhury S, Moate R, Krishnan KR, Archer G, Modell JG, Alexander R, Zamuner S, Lavergne A, Evoniuk G, Ratti E. Efficacy, safety, and tolerability of a triple reuptake inhibitor GSK372475 in the treatment of patients with major depressive disorder: two randomized, placebo- and active-controlled clinical trials. J Psychopharmacol. 2012 May;26(5):653-62. doi: 10.1177/0269881111424931. Epub 2011 Nov 2.
Other Identifiers
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SND 103285
Identifier Type: -
Identifier Source: org_study_id
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