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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00448058
First received: March 13, 2007
Last updated: November 10, 2011
Last verified: November 2011
History of Changes

March 13, 2007
November 10, 2011
April 2007
December 2008   (final data collection date for primary outcome measure)
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 ]
Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale.
Complete list of historical versions of study NCT00448058 on ClinicalTrials.gov Archive Site
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) ]
Endpoints related to response & remission on depression rating scales during time of treatment exposure Change during treatment & at endpoint-week 10:in Clinical Global Impression scale; in motivation, energy, & sexual functioning on patient-rated scales
Not Provided
Not Provided
 
A Study Of New Medicine (GSK 372475) For The Treatment Of Depression
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)

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Depressive Disorder
  • Major Depressive Disorder (MDD)
  • Drug: GSK372475
    daily administration during the 10-week treatment phase
    Other Name: GSK372475
  • Drug: venlafaxine
    daily administration during the 10-week treatment phase
  • 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
    Intervention: Drug: GSK372475
  • Active Comparator: Venlafaxine
    Flexible- dose design from Venlafaxine XR 75 mg/day to Venlafaxine XR 225 mg/day
    Intervention: Drug: venlafaxine
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
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. Epub 2011 Nov 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
396
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Bulgaria,   Canada,   Estonia,   Finland,   France,   Germany,   India,   Poland,   Slovakia,   South Africa
 
NCT00448058
SND 103285
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP