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Clinical Study to Test a New Drug to Treat Major Depression

NCT ID: NCT00976560

Last Updated: 2017-11-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-25

Study Completion Date

2010-07-07

Brief Summary

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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.

Detailed Description

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Conditions

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Depressive Disorder, Major

Keywords

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Lack of interest and energy Psychomotor retardation Cytokines Major Depressive disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GW856553

GW856553 7.5 mg BID

Group Type EXPERIMENTAL

GW856553

Intervention Type DRUG

Wet Granulated, film coated white, 9mm round, biconvex, plain faced tablets, containing 7.5 mg of GW856553

Placebo

Matching Placebo BID

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Film coated white, 9mm round, biconvex, plain faced tablets obtained by direct compression.

Interventions

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GW856553

Wet Granulated, film coated white, 9mm round, biconvex, plain faced tablets, containing 7.5 mg of GW856553

Intervention Type DRUG

Placebo

Film coated white, 9mm round, biconvex, plain faced tablets obtained by direct compression.

Intervention Type OTHER

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Hoffman Estates, Illinois, United States

Site Status

GSK Investigational Site

Park Ridge, Illinois, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

Columbus, Ohio, United States

Site Status

GSK Investigational Site

Pazardzhik, , Bulgaria

Site Status

GSK Investigational Site

Plovdiv, , Bulgaria

Site Status

GSK Investigational Site

Rousse, , Bulgaria

Site Status

GSK Investigational Site

Sofia, , Bulgaria

Site Status

GSK Investigational Site

Tartu, , Estonia

Site Status

GSK Investigational Site

Hüttenberg, Hesse, Germany

Site Status

GSK Investigational Site

Achim, Lower Saxony, Germany

Site Status

GSK Investigational Site

Westerstede, Lower Saxony, Germany

Site Status

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, Germany

Site Status

GSK Investigational Site

Bielefeld, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Dresden, Saxony, Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Saint Petersburg, , Russia

Site Status

GSK Investigational Site

Samara, , Russia

Site Status

GSK Investigational Site

Smolensk, , Russia

Site Status

Countries

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United States Bulgaria Estonia Germany Russia

Study Documents

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Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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113009

Identifier Type: -

Identifier Source: org_study_id