Clinical Study to Test a New Drug to Treat Major Depression
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 11/16/2017 |
| Start Date: | September 25, 2009 |
| End Date: | July 7, 2010 |
A Six Week Randomized, Double-blind, Multi-center, Placebo-controlled, 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
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.
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.
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
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