A Study Of New Medicine (GSK 372475) For The Treatment Of Depression - Full Text View

Purpose

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

Condition	Intervention	Phase
Depressive Disorder Major Depressive Disorder (MDD)	Drug: GSK372475 Drug: venlafaxine Drug: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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) ]

Enrollment:	396
Study Start Date:	April 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Other Name: GSK372475
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
Placebo Comparator: placebo	Drug: placebo daily administration during the 10-week treatment phase

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

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448058

Show 39 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00448058 History of Changes
Other Study ID Numbers:	SND 103285
Study First Received:	March 13, 2007
Last Updated:	November 10, 2011
Health Authority:	Canada: Health Canada

Keywords provided by GlaxoSmithKline:

GSK372475
Major Depressive Disorder
Flexible-dose
Venlafaxine XR
MDD

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013