A Study to Investigate the Effects of GW876008 on Brain Activation During Emotional Processing in Healthy Subjects.
This study has been completed.
Information provided by:
First received: January 17, 2007
Last updated: October 13, 2010
Last verified: October 2010
Data suggests that imaging activity of the brain can measure the effects of anti-anxiety drugs. This study will investigate the effect of GW876008 on areas of the brain involved with thinking and emotion
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Primary Purpose: Diagnostic
|Official Title:||A Randomized, Placebo-controlled, Double-dummy, Four-way Crossover Design Study to Investigate the Changes of fMRI BOLD Activation Induced by Emotional Activation Paradigms Following Single Doses of GW876008 and Lorazepam (Comparator) in Healthy Subjects.|
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Differences in brain activation elicited by Matching Emotional Face Expression paradigm following single oral doses of GW876008 and lorazepam on day 1, sessions 1-4
Secondary Outcome Measures:
- GW876008 blood levels [ Time Frame: pre-dose & post-dose, sessions 1-4 ]
- clinical rating scales change after dosing: questionnaires collected [ Time Frame: pre-dose & up to 6-8 hours post-dose. ]
- Safety: 12-lead ECG, vital signs, adverse events, clinical labs
- fMRI BOLD neuroanatomical structure of the emotional brain neurocircuitry and connectivity
- fMRI BOLD Signal characteristics and connectivity
- fMRI BOLD Response in the emotional brain neurocircuitry and occipital cortex.
- ETCo2 in mm Hg, to be recorded for the duration of the scan session and be synchronized with the single fMRI procedure timing
- Visual Analog Scale (VAS) measurements of sleepiness, alertness, calm, tension, and anxiety performed before dosing (baseline), pre-fMRI session, post-fMRI session and just before leaving the facility.
- Association between the anxiety trait (STAI-trait, test battery for neuroticism or liability for Anxiety Disorders) collected at screening and the various pharmacodynamic parameters measured in the various testing conditions.
- GW876008 concentration to determine pharmacokinetic parameters to be collected twice per session,
- Pharmacogenetic (PGx) assessments
- Safety and tolerability of GW876008 to include Vital signs semi-supine; respiratory rate, pulse oximetry and ECG.
- Clinical laboratory tests
- fMRI BOLD ALS signal.
- Heart rate (HR; beats per minute), to be recorded for the whole duration of the scan session and to be synchronized with the single fMRI procedure timing.
- Respiratory rate (RR: inspiration per minute), to be recorded for the duration of scan session and be synchronized with the single fMRI procedure timing. .
|Study Start Date:||March 2007|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424697
|United States, California|
|GSK Investigational Site|
|La Jolla, California, United States, 92093|
Sponsors and Collaborators
|Study Director:||GSK Clinical Trials, MBChB, MFPM||GlaxoSmithKline|