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 18, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Depressive Disorder, Major
Drug: GW856553X
Phase 2

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: September 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
GW856553X 7.5mg BID for 6 weeks
Drug: GW856553X
GW856553X 7.5mg BID for 6 weeks
Placebo Comparator: Placebo
Placebo to match, BID, 6 weeks
Drug: GW856553X
GW856553X 7.5mg BID for 6 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569062

Locations
Estonia
GSK Investigational Site
Tartu, Estonia, 50417
India
GSK Investigational Site
Bangalore, India, 560029
GSK Investigational Site
Bangalore City, India, 560034
GSK Investigational Site
Ludhiana, India, 141001
GSK Investigational Site
Manipal,, India, 576 104
GSK Investigational Site
Mumbai, India, 400010
GSK Investigational Site
Pune, India, 411004
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 119992
GSK Investigational Site
Moscow, Russian Federation, 123367
GSK Investigational Site
Moscow, Russian Federation, 107076
GSK Investigational Site
Moscow, Russian Federation, 115522
GSK Investigational Site
Nizhny Novgorod, Russian Federation, 603115
GSK Investigational Site
Smolensk, Russian Federation, 214 019
GSK Investigational Site
St-Petersburg, Russian Federation
GSK Investigational Site
St.Petersburg, Russian Federation, 193167
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00569062     History of Changes
Other Study ID Numbers: PKI108574
Study First Received: December 5, 2007
Last Updated: October 18, 2013
Health Authority: India: Ministry of Health
Estonia: The State Agency of Medicine
Russia: Ministry of Health of the Russian Federation

Keywords provided by GlaxoSmithKline:
Psychomotor retardation,
Major Depressive Disorder (MDD),
cytokines
GW856553,

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

ClinicalTrials.gov processed this record on April 17, 2014