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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00424697 |
Purpose
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 |
|---|---|---|
|
Healthy Subjects |
Drug: placebo Drug: lorazepam Drug: GW876008 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind 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. |
| 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) |
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| GSK Investigational Site | |
| La Jolla, California, United States, 92093 | |
| Study Director: | GSK Clinical Trials, MBChB, MFPM | GlaxoSmithKline |
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00424697 History of Changes |
| Other Study ID Numbers: | CRH104150 |
| Study First Received: | January 17, 2007 |
| Last Updated: | October 13, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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Brain imaging, fMRI, stimulation, |
pharmacodynamics, tolerability, healthy subjects |
|
Lorazepam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents |
Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |