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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00424697 |
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
Condition | Intervention | Phase |
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Healthy Subjects |
Drug: placebo Drug: lorazepam Drug: GW876008 |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double-Blind, Crossover Assignment, Pharmacodynamics Study |
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. |
Enrollment: | 26 |
Study Start Date: | March 2007 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
GSK Investigational Site | |
La Jolla, California, United States, 92093 |
Study Director: | GSK Clinical Trials, MBChB, MFPM | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | CRH104150 |
Study First Received: | January 17, 2007 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00424697 |
Health Authority: | United States: Food and Drug Administration |
Brain imaging, fMRI, stimulation, |
pharmacodynamics, tolerability, healthy subjects |
Naphazoline Lorazepam Oxymetazoline Guaifenesin |
Phenylephrine Phenylpropanolamine Healthy |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |