A Study of GW856553X For the Treatment of Depression - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00569062

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
Major Depressive Disorder (MDD)	Drug: GW856553X	Phase II

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	120
Study Start Date:	September 2007

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
3 Block, Koramangala, Bangalore, India, 560034
GSK Investigational Site
Pune, India, 411004
GSK Investigational Site
Ludhiana, India, 141001
GSK Investigational Site
Bangalore, India, 560029
GSK Investigational Site
Mumbai, India, 400010
Russian Federation
GSK Investigational Site
St.Petersburg, Russian Federation, 193167
GSK Investigational Site
St-Petersburg, Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 123367
GSK Investigational Site
Smolensk, Russian Federation, 214 019
GSK Investigational Site
Nizhny Novgorod, Russian Federation, 603115
GSK Investigational Site
Moscow, Russian Federation, 107076
GSK Investigational Site
Moscow, Russian Federation, 119992
GSK Investigational Site
Moscow, Russian Federation, 115522

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	PKI108574, 108574
Study First Received:	December 5, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00569062
Health Authority:	Russia: Ministry of Health and Social Development of the Russian Federation; Estonia: The State Agency of Medicine; India: Ministry of Health

Keywords provided by GlaxoSmithKline:

GW856553,
Major Depressive Disorder (MDD),
Psychomotor retardation,
cytokines

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 15, 2009