MDD POC Study GSK372475 Subjects Depressive Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00420641
First received: January 10, 2007
Last updated: June 26, 2014
Last verified: June 2014
  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
Depressive Disorder
Drug: GSK372475
Drug: Paroxetine
Other: Placebo
Phase 2

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


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: Week 10 ] [ Designated as safety issue: No ]

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 [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
  • Endpoints related to response and remission on depression rating scales during time of treatment exposure [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Week 10 ] [ Designated as safety issue: No ]

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)
Arms Assigned Interventions
Experimental: GSK372475 Arm
GSK372475 1.0- 1.5 mg/day
Drug: GSK372475
GSK372475 1.0-1.5 mg/day
Experimental: Paroxetine Arm
Paroxetine 20-30 mg/day
Drug: Paroxetine
Paroxetine 20-30 mg/day
Placebo
Placebo to Match
Other: Placebo
Placebo to Match

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00420641     History of Changes
Other Study ID Numbers: SND 103288
Study First Received: January 10, 2007
Last Updated: June 26, 2014
Health Authority: Canada: Health Canada

Keywords provided by GlaxoSmithKline:
MDD
flexible-dose
Major Depressive Disorder
paroxetine
GSK372475

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Paroxetine
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 July 20, 2014