Clinical Study to Test a New Drug to Treat Major Depression (PKI113009)
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00976560
First received: September 11, 2009
Last updated: March 15, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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 |
Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013