Clinical Study to Test a New Drug to Treat Major Depression

NCT00976560 | Completed Phase 2 Results

• 1 other identifier: 113009
• Study Type: interventional
• Target: 128
• Locations: 5 countries
• Sites: 21

Brief Summary

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.

Conditions

Depressive Disorder, Major

Keywords

Lack of interest and energy; Psychomotor retardation; Cytokines; Major Depressive disorder

Outcome Measures

Primary Outcomes (1)

• Change From Randomization (Week 0) Associated With GW856553 Versus Placebo at Week 6 in the Bech (6-item HAMD-17 [Hamilton Depression Rating Scale]) Score.

  HAMD-17 has 17 questions. The HAMD-17 Total Score was calculated by summing the individual response scores over the 17 individual components of the interview. The highest possible score was 52, which represented the most severe measure of depression; the lowest possible score was 0, which represented an absence of depression. There were 9 five point questions and 8 three point questions. The responses to the individual questions had values of 0-2 (three points response) or 0-4 (five points response). The BECH scale was extracted from the HAMD-17 and comprises of 6 items out of which 5 are 5 point questions and 1 is 3 point question. The Bech Total Score was calculated by summing the individual response scores and ranged from 0 to 22, with higher scores indicating more severe depression. Week 0 values were considered as Baseline.The change from randomization was analysed using suitable Bayesian mixed-effects model repeated measures (BMMRM) assuming missing at random (MAR).

  At Week 6

Secondary Outcomes (21)

• Number of Participants With Adverse Events

  6 Weeks

• Number of Participants With Suicidality as Assessed by the Columbia Suicidality Severity Rating Scale Score

  Upto Week 6

• Number of Participants With Abnormal Haematology and Clinical Chemistry Values

  Upto Week 6

• Number of Participants With Abnormal Vital Signs (Blood Pressure, Heart Rate)

  Up to follow-up Visit (Day 53)

• Number of Participants With Abnormal Electrocardiogram (ECG) Findings

  Up to follow-up Visit (Day 53)

Study Arms (2)

GW856553

EXPERIMENTAL

GW856553 7.5 mg BID

Drug: GW856553

Placebo

PLACEBO COMPARATOR

Matching Placebo BID

Other: Placebo

Interventions

GW856553 DRUG

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

GW856553

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (21)

GSK Investigational Site

Hoffman Estates, Illinois, 60169, United States

Location

GSK Investigational Site

Park Ridge, Illinois, 60068, United States

Location

GSK Investigational Site

New York, New York, 10128, United States

Location

GSK Investigational Site

Columbus, Ohio, 43210, United States

Location

GSK Investigational Site

Pazardzhik, 4400, Bulgaria

Location

GSK Investigational Site

Plovdiv, 4000, Bulgaria

Location

GSK Investigational Site

Rousse, Bulgaria

Location

GSK Investigational Site

Sofia, 1113, Bulgaria

Location

GSK Investigational Site

Tartu, 50417, Estonia

Location

GSK Investigational Site

Hüttenberg, Hesse, 35625, Germany

Location

GSK Investigational Site

Achim, Lower Saxony, 28832, Germany

Location

GSK Investigational Site

Westerstede, Lower Saxony, 26655, Germany

Location

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 19053, Germany

Location

GSK Investigational Site

Bielefeld, North Rhine-Westphalia, 33647, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01097, Germany

Location

GSK Investigational Site

Berlin, 10629, Germany

Location

GSK Investigational Site

Moscow, 107076, Russia

Location

GSK Investigational Site

Moscow, 125367, Russia

Location

GSK Investigational Site

Saint Petersburg, Russia

Location

GSK Investigational Site

Samara, 443016, Russia

Location

GSK Investigational Site

Smolensk, 214 019, Russia

Location

Related Links

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

MeSH Terms

Conditions

Depressive Disorder, Major; Psychomotor Disorders

Interventions

6-(5-((cyclopropylamino)carbonyl)-3-fluoro-2-methylphenyl)-N-(2,2-dimethylprpyl)-3-pyridinecarboxamide

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: September 25, 2009
• Primary Completion: July 7, 2010
• Study Completion: July 7, 2010
• Last Updated: November 14, 2017
• Results First Posted: November 14, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (7); US (4); BU (4); ES (1); RU (5)