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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00976560
First received: September 11, 2009
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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 reducing 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.


Condition Intervention Phase
Depressive Disorder, Major
Drug: GW856553
Other: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 180
Study Start Date: September 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1
GW856553 2.5 mg BID
Drug: GW856553
Wet granulated tablets, film coated white, 9mm round, biconvex, plain faced, containing 2.5 mg of GW856553
Experimental: Dose 2
GW856553 7.5 mg BID
Drug: GW856553
Wet Granulated, film coated white, 9mm round, biconvex, plain faced tablets, containing 7.5 mg of GW856553
Placebo Comparator: Placebo
Matching Placebo BID
Other: Placebo
Film coated white, 9mm round, biconvex, plain faced tablets obtained by direct compression.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00976560

Locations
United States, Illinois
GSK Investigational Site
Hoffman Estates, Illinois, United States, 60169
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
United States, New York
GSK Investigational Site
New York, New York, United States, 10128
United States, Ohio
GSK Investigational Site
Columbus, Ohio, United States, 43210
Bulgaria
GSK Investigational Site
Pazardzhik, Bulgaria, 4400
Estonia
GSK Investigational Site
Tartu, Estonia, 50417
Germany
GSK Investigational Site
Huettenberg, Hessen, Germany, 35625
GSK Investigational Site
Schwerin, Mecklenburg-vorpommern, Germany, 19053
GSK Investigational Site
Achim, Niedersachsen, Germany, 28832
GSK Investigational Site
Westerstede, Niedersachsen, Germany, 26655
GSK Investigational Site
Bielefeld, Nordrhein-westfalen, Germany, 33647
GSK Investigational Site
Dresden, Sachsen, Germany, 01097
GSK Investigational Site
Berlin, Germany, 10629
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 107076
GSK Investigational Site
Moscow, Russian Federation, 125367
GSK Investigational Site
Samara, Russian Federation, 443016
GSK Investigational Site
Smolensk, Russian Federation, 214 019
GSK Investigational Site
St-petersburg, Russian Federation
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00976560     History of Changes
Other Study ID Numbers: 113009
Study First Received: September 11, 2009
Last Updated: March 15, 2012
Health Authority: Estonia: State Agency of Medicines
Bulgaria: The Bulgarian Drug Agency
Russian Federation: Federal service on surveillance in healthcare and social development of Russian Federation
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Lack of interest and energy
Psychomotor retardation
Cytokines
Major Depressive disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014