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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00420641

Purpose

To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the treatment of outpatients subjects with major depressive disorder to exhibit decreased pleasure, interest and energy.

Condition	Intervention	Phase
Major Depressive Disorder (MDD)	Drug: GSK372475	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled, Paralleled-Group, Flexible-Dose Study Evaluating the Efficacy, Safety and Tolerability of GSK372475 or Paroxetine Compared to Placebo in Adult Subjects Diagnosed With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Paroxetine

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.

Secondary Outcome Measures:

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
Endpoints related to response and remission on depression rating scales during time of treatment exposure
Change during treatment at a week 10 endpoint in Clinical Global Impression, and in motivation, energy and sexual functioning on patient-rated scales Assessment of suicidality

Estimated Enrollment:	492
Study Start Date:	December 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

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 panic disorder / attacks, generalised anxiety, borderline or antisocial personality disorder, dementia, anorexia nervosa / bulimia (within 6 months of screening), bipolar disorder, schizophrenia or any other psychotic disorder(s).
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: NCT00420641

Show 33 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SND 103288, TBD
Study First Received:	January 10, 2007
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00420641 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by GlaxoSmithKline:

Major Depressive Disorder
MDD
GSK372475
paroxetine
flexible-dose

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major

Depressive Disorder
Paroxetine
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease
Depression
Mental Disorders

Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 09, 2009