Clinical Study to Test a New Drug to Treat Major Depression (PKI113009)

Tracking Information

Start Date  ICMJESeptember 2009
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: September 11, 2009)
Clinical antidepressant effects of GW856553 measured as change from baseline in the Bech Score (6-items HAMD 17) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00976560 on Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: September 11, 2009)
  • Safety and tolerability of GW856553 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Decrease of circulating plasma cytokines after GW856553 administration [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEClinical Study to Test a New Drug to Treat Major Depression
Official Title  ICMJEA Six Week Randomized, Double-blind, Multi-center, Placebo-controlled, Exploratory, Adaptive Design Study to Explore the Antidepressant Properties of the p38 MAP Kinase Inhibitor GW856553 Compared to Placebo in Adult Subjects With Major Depressive Disorder
Brief Summary

In this randomized, double-blind, multi-centre, placebo controlled, exploratory, adaptive design study, the antidepressant and plasma cytokine lowering effects of the GW856553 will be investigated in adult subjects diagnosed with MDD. Subjects will receive oral doses of GW856553 or placebo for six weeks. Safety, tolerability, pharmacokinetics and pharmacodynamics, defined as biomarkers in blood and clinical symptoms, will be assessed.

The primary endpoint is the change from baseline associated with GW856553 versus placebo at Week 6 in the Bech (6-item HAMD-17) score. Interim analyses of the primary endpoint will be performed throughout the study to potentially adapt the study design by changing the randomization ratio and/ or the total number of subjects to be randomized into the study. Exploratory analyses will be performed by associating changes in cytokine levels and selected clinical symptoms; PK/PD modelling will also be used to identify the most sensitive clinical and biological markers.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEMajor Depressive Disorder (MDD)
Intervention  ICMJE
  • Drug: GW856653
    Wet Granulated, film coated white, 9mm round, biconvex, plain faced tablets, containing 7.5 mg of GW856553
  • Other: Placebo
    Film coated white, 9mm round, biconvex, plain faced tablets obtained by direct compression.
  • Drug: GW856653
    Wet granulated tablets, film coated white, 9mm round, biconvex, plain faced, containing 2.5 mg of GW856553
Study Arms / Comparison Groups
  • Dose 1: Experimental
    GW856553 2.5 mg BID
    Intervention: Drug: GW856653
  • Dose 2: Experimental
    GW856443 7.5 mg BID
    Intervention: Drug: GW856653
  • Placebo: Placebo Comparator
    Placebo of GW856553 BID
    Intervention: Other: Placebo

Recruitment Information

Estimated Enrollment  ICMJE180
Estimated Completion DateAugust 2010
Estimated Primary Completion DateAugust 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Adult subjects with primary diagnosis of moderate to severe MDD without psychotic features, for at least 4 weeks and one previous MDD episode
  • Males or Females who agree to use protocol specified contraception if of child bearing potential
  • BMI 18.5-35.0 kg/m2
  • Normal liver function tests

Key Exclusion Criteria:

  • History of liver disease or positive hepatitis B surface antigen or hepatitis C antibody in the last 3 months
  • Elevated liver function tests on >2 ocassions in the last 7 months
  • Significant medical illness, autoimmune disease or infectious disease
  • Pregnant or nursing females
  • Excessive and regular alcohol consumption
  • History of substance abuse or dependence in past 6 months or positive urine drug screen
  • Significant suicidal or homicidal risk
  • Currently receiving chronic biological or pharmacologic anti-inflammatory therapy or is not euthyroid
  • Psychoactive drugs within 1 week or 5 half lives of randomization visit
  • Treatment resistant subjects
Ages18 Years to 60 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: US GSK Clinical Trials Call Center877-379-3718
Location Countries  ICMJEUnited States,   Bulgaria,   Estonia,   Russian Federation

Administrative Information

Responsible PartyStudy Director, GSK
Study ID Numbers  ICMJE113009
Study Sponsor  ICMJEGlaxoSmithKline
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:GSK Clinical TrialsGlaxoSmithKline
Information Provided ByGlaxoSmithKline
Verification DateJanuary 2010