Safety and Efficacy Study in Patients With Major Depressive Disorder


Tracking Information

Start Date  ICMJEApril 2009
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: May 7, 2009)
  • Efficacy - To evaluate the antidepressant efficacy of GSK163090 versus placebo in the treatment of subjects diagnosed with Major Depressive Disorder (MDD) during the first 2 weeks of treatment. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Efficacy - To evaluate the antidepressant efficacy of GSK163090 versus placebo in the treatment of subjects diagnosed with Major Depressive Disorder (MDD) after 6 weeks of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Safety and Tolerability - To assess the safety and tolerability of GSK163090 compared to placebo in subjects diagnosed with MDD. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00896363 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: May 7, 2009)		To investigate preliminary pharmacokinetic/pharmacodynamic relationships for GSK163090 in subjects with MDD. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJESafety and Efficacy Study in Patients With Major Depressive Disorder
Official Title  ICMJEA Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder.
Brief Summary

The purpose of this study is to test if GSK163090 can reduce the symptoms of depression. The safety and how well the body can handle the drug will also be investigated. The study will be conducted in Russia in hospitalised patients with severe depression. GSK163090 will be compared with placebo, which looks like the study drug but does not contain any active substance. Subjects will be given either the study drug or the matching placebo.

Detailed Description

This is a randomised, multi-centre, double-blind, placebo-controlled, repeat dose, parallel group study in male and female patients with severe depression requiring hospitalization. Efficacy, safety and tolerability will be assessed in three treatment arms. The study will consist of a screening period, a treatment phase (up to 6 weeks) and a post-treatment follow-up visit. The study duration from screening to follow up will be approximately 9 weeks. Subjects who pass screening will be randomized on Day 1 to one of three treatment arms (low dose arm, high dose arm or placebo). Each treatment arm will contain approximately 50 subjects. The subject's depressive symptoms will be assessed using the HAMD17- CR.

Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Condition  ICMJE
  • Major Depressive Disorder (MDD)
  • Major Depressive Episode
Intervention  ICMJE
  • Drug: GSK163090 Tablets
    Developed for the treatment of Major Depressive Disorder
  • Drug: GSK163090 Placebo Tablets
    Developed for the treatment of Major Depressive Disorder
Study Arms / Comparison Groups
  • Active: Active Comparator
    Parallel Group - High Dose Arm, Low Dose Arm
    Intervention: Drug: GSK163090 Tablets
  • Placebo: Placebo Comparator
    Parallel Group
    Intervention: Drug: GSK163090 Placebo Tablets

Recruitment Information

Estimated Enrollment  ICMJE150
Estimated Completion DateJune 2010
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Currently have severe depression (Major Depressive Disorder - without psychotic features)
  • meet criteria (DSM IV-TR ) for current major depressive episode for at least 4 weeks but for no greater than 24 months
  • depression questionnaire (HAMD17) total score greater than or equal to 24
  • subject must read and able to give written informed consent
  • male or female 18 to 64 years
  • use appropriate birth control method
  • BMI 18.8 - 35.0 kg/m2 (inclusive)

Exclusion Criteria:

  • Primary diagnosis of other psychiatric disorders
  • thoughts of killing ones self or someone else
  • taking psychiatric medicine or therapy within the six months
  • Has previously failed an adequate course of medication for MDD from two different classes of antidepressants.
  • Unstable medical disorder or a disorder that would interfere with the action of the drug
  • Abuse of alcohol or drugs
  • Past history of serotonin syndrome or a history of clinical significant intolerance of SSRIs (class of drugs used for depression).
  • History of migraine headaches that respond to treatment with triptan medication.
  • History of a clinically significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizure (excluding febrile seizure).
  • Currently taking part in another clinical study or has done so within six months
  • Pregnant, planning to become pregnant shortly or breastfeeding
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy
GenderBoth
Ages18 Years to 64 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: US GSK Clinical Trials Call Center877-379-3718
Location Countries  ICMJERussian Federation

Administrative Information

NCT ID  ICMJENCT00896363
Responsible PartyStudy Director, GSK
Study ID Numbers  ICMJE109035
Study Sponsor  ICMJEGlaxoSmithKline
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:GSK Clinical TrialsGlaxoSmithKline
Information Provided ByGlaxoSmithKline