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MDD POC Study GSK372475 Subjects Depressive Disease

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ClinicalTrials.gov Identifier: NCT00420641
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Depressive Disorder Drug: GSK372475 Drug: Paroxetine Other: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 492 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2006
Primary Completion Date : June 2008
Study Completion Date : June 2008


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale. [ Time Frame: Week 10 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Endpoints related to response and remission on depression rating scales during time of treatment exposure [ Time Frame: Week 10 ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420641


  Show 33 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Publications:
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;

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
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: June 2014

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

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors