A six week randomized, double-blind, multi-center, placebocontrolled, 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.

GlaxoSmithKline Research & Development Ltd0 sites180 target enrollmentAugust 10, 2009

ConditionsMajor Depressive Disorder MedDRA version: 12.0Level: LLTClassification code 10025453Term: Major depressive disorder NOS

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Major Depressive Disorder
Sponsor: GlaxoSmithKline Research & Development Ltd
Enrollment: 180
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 10, 2009

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Research & Development Ltd

Eligibility Criteria

Inclusion Criteria

•1\. The subject is male or female \= 18 years of age and \= 60 years.
•To be eligible, female subjects must have a negative pregnancy test (i.e. serum beta hCG test) and be of:
•a. Non\-childbearing potential defined as pre\-menopausal females with a documented
•tubal ligation or hysterectomy; or postmenopausal defined as 12 months of
•spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous
•follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml (\<140
•pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and
•whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8\.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post\-menopausal status prior to study enrollment. For most forms of HRT, at least 2\-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post\-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
•b. Child\-bearing potential and agrees to use one of the contraception methods listed in Section 8\.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of
•pregnancy at that point. Female subjects must agree to use contraception until the

Exclusion Criteria

•1\. History of excessive regular alcohol consumption within 3 months of the study defined as:
•\- For non\-US sites: an average weekly intake of \>21 units (or average daily intake \>3 units) for males or \>14 units (or average daily intake \>2 units) for females. One unit is equivalent to 8 g of alcohol: a half\-pint (\~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
•\- For US sites: an average weekly intake of \>14 drinks (or average daily intake \>2 drinks) for males or \>7 drinks (or average daily intake \>1 drink) for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1\.5 ounces (45 ml) of 80 proof distilled spirits
•2\. The subject has any history of liver disease.
•3\. A positive pre\-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
•4\. The subject has a history of elevated liver function tests on more than one occasion (ALT, AST, and total bilirubin \> 2 x ULN or ALP \> 3 x ULN) in the past 7 months.
•5\. The subject has a significant cardiac, pulmonary, metabolic, renal, or gastrointestinal disease that, in the opinion of the investigator, places the subject at an unacceptable risk as a participant in this trial.
•6\. The subject has a history of autoimmune diseases.
•7\. The subject has any active infectious diseases, including active tuberculosis or a history of active tuberculosis.
•8\. The subject has a history of malignancy, except for surgically cured basal cell carcinoma or females with cured cervical carcinoma (\> 2 yrs prior).