Clinical trial NCT00448058: A Study Of New Medicine (GSK 372475) For The Treatment Of Depression
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder
Keywords: Flexible-dose
GSK372475
MDD
Venlafaxine XR
Major Depressive Disorder
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-03-15
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale.
timeFrame: Randomisation (week 0) And end of the treatment
Secondary outcomes:
measure: 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
timeFrame: Randomisation (week 0) and at weeks 1,2,4,6,8 and week 10 (end of treatment phase)
Other outcomes:
Locations:
city: Auchenflower
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Kippa Ring
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Epping
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Heidelberg West
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Liège
country: Belgium
facility: GSK Investigational Site
city: Mont-Godinne
country: Belgium
facility: GSK Investigational Site
city: Burgas
country: Bulgaria
facility: GSK Investigational Site
city: Varna
country: Bulgaria
facility: GSK Investigational Site
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Sydney
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Sydney
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Burlington
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Voru
country: Estonia
facility: GSK Investigational Site
city: Kuopio
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Arcachon
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Toulouse
country: France
facility: GSK Investigational Site
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Unterhaching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Schwerin
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Westerstede
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Bangalore
country: India
facility: GSK Investigational Site
city: Chennai
country: India
facility: GSK Investigational Site
city: Hyderabad
country: India
facility: GSK Investigational Site
city: Tirupati
country: India
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Gdansk
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Skorzewo
country: Poland
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Michalovce
country: Slovakia
facility: GSK Investigational Site
city: Observatory ,Cape Town
country: South Africa
facility: GSK Investigational Site
city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Vereeniging
country: South Africa
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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;
citation: 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.