Clinical Study to Test a New Drug to Treat Major Depression (PKI113009)

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Depressive Disorder, Major

Treatments

Other: Placebo

Drug: GW856553

Study type

Interventional

Funder types

Industry

Identifiers

NCT00976560

113009

Details and patient eligibility

About

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.

Enrollment

128 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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