Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of GW856553X For the Treatment of Depression

This study has been terminated.
(Negative data from a GSK PoC study in RA combined with evidence of greater sensitivity of toll-like receptor pathways to p38 inhibition.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00569062
First received: December 5, 2007
Last updated: October 14, 2014
Last verified: October 2014

December 5, 2007
October 14, 2014
September 2007
June 2008   (final data collection date for primary outcome measure)
Effect of 6 weeks treatment with GW856553X on depressive symptoms, as measured by changes in scores depression rating scales.Effect of 6 weeks treatment with GW856553X on the levels of selected cytokines [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Effect of 6 weeks treatment with GW856553X on depressive symptoms, as measured by changes in scores depression rating scales. Effect of 6 weeks treatment with GW856553X on the levels of selected cytokines [ Time Frame: 6 Weeks ]
Complete list of historical versions of study NCT00569062 on ClinicalTrials.gov Archive Site
Effect of 6 weeks treatment with GW856553X on Global Depressive Symptoms and on the putative cytokine related intermediate phenotypesEffect of treatment with GW856553X on inflammatory and exploratory biomarkers at weeks 2 and 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Effect of 6 weeks treatment with GW856553X on Global Depressive Symptoms and on the putative cytokine related intermediate phenotypes Effect of treatment with GW856553X on inflammatory and exploratory biomarkers at weeks 2 and 6 [ Time Frame: 6 Weeks ]
Not Provided
Not Provided
 
A Study of GW856553X For the Treatment of Depression
A Randomized, Double Blind, Placebo Controlled Study to Explore the Antidepressant Properties of P38a Kinase Inhibitor GW856553X 15mg Compared to PBO in Subjects With Major Depressive Disorder Exhibiting Symptoms of Loss of Energy and Interest and Psychomotor Retardation, for a Six Week Treatment Period

GW856553 is a novel compound, currently in development for the treatment of Major Depressive Disorder (MDD), and other indications. GW856553 inhibits a protein which is responsible for the production of some pro-inflammatory molecules, called cytokines. Increased blood levels of these molecules were seen in populations of MDD patients and this was more apparent in subjects with severe symptoms, psychomotor retardation and loss of energy. Aim of the present study is to assess whether GW856553, by inactivating this protein, is able to suppress the production of the cytokines, and ultimately relieving depression symptoms. In this study GW856553 or placebo is given to MDD patients 7.5md twice daily for 6 weeks.

A randomised, double-blind, placebo-controlled study to explore the antidepressant properties of the P38a kinase inhibitor GW856553X 15mg compared to placebo in subjects with Major Depressive Disorder exhibiting symptoms of loss of energy and interest, and psychomotor retardation, for a six week treatment period.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Depressive Disorder, Major
Drug: GW856553X
GW856553X 7.5mg BID for 6 weeks
  • Experimental: Arm 1
    GW856553X 7.5mg BID for 6 weeks
    Intervention: Drug: GW856553X
  • Placebo Comparator: Placebo
    Placebo to match, BID, 6 weeks
    Intervention: Drug: GW856553X
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female = 18 years of age and < 60 years,
  • routine laboratory results within normal ranges,
  • Body Mass Index within the range 18.5-35.0 kg/m2 inclusive.
  • Subject must have had at least one previous major depressive episode with a diagnosis of MDD in his/her history, and had a successful pharmacological treatment of that episode, and is currently experiencing a recurrence of MDD presently un-medicated.
  • Subjects must met the diagnosis of an episode of Major Depressive Disorder in the past 12 weeks but not greater than 24 months.

Exclusion Criteria:

  • The subject has any history of liver disease.
  • The subject has significant cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions that, in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as a participant in this trial.
  • The subject has a history of autoimmune diseases.
  • The subject has any active infectious diseases, including active tuberculosis or a history of active tuberculosis.
  • The subject has a history of malignancy, except for surgically cured basal cell carcinoma or females with cured cervical carcinoma (> 2 yrs prior).
  • The subject has a history of HIV or other immunosuppressive disease.
  • The subject has uncontrolled diabetes.
  • The subject is pregnant or nursing.
  • Subject has no contact with an adult on a daily basis (i.e., subjects who are not living with at least one other adult or subjects who do not have an adult who contacts them on a daily basis).
  • Subject has initiated psychotherapy within three months prior to the Screening visit, or plans to initiate psychotherapy during the trial.
  • Subject has received electroconvulsive therapy or transcranial magnetic stimulation or vagal nerve stimulation within the six months prior to the Screening.
  • The subject is currently receiving a chronic biological or pharmacologic anti-inflammatory therapy; interferon therapy at any dose or did receive them within 6 months prior randomisation.
  • Subjects who have donated a unit of blood within the previous month or intends to donate in the month after completing the study
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Estonia,   India,   Russian Federation
 
NCT00569062
PKI108574
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP