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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00555139 |
Purpose
To compare by neuroimaging techniques and public speaking, the way social anxiety patients respond after the administration of GW876008, GSK561679, alprazolam and placebo
| Condition | Intervention | Phase |
|---|---|---|
|
Social Anxiety Disorder |
Drug: GSK561679 Drug: GW876008 Drug: alprazolam |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Double-blind, Randomized, Placebo and Alprazolam-controlled Three-period Crossover Incomplete Block Design Study to Compare Putative Anxiolytic-like fRMI Activity of GW876008 and GSK561679 After Single-dose Administration in Subjects With Social Anxiety Disorder (SAD) |
| Enrollment: | 35 |
| Study Start Date: | March 2007 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| Spain | |
| GSK Investigational Site | |
| Barcellona, Spain, 08025 | |
| GSK Investigational Site | |
| Barcelona, Spain, 08025 | |
| GSK Investigational Site | |
| Barcelona, Spain, E-08003 | |
| GSK Investigational Site | |
| Barcelona, Spain | |
| GSK Investigational Site | |
| Barcelona, Spain, 08035 | |
| GSK Investigational Site | |
| Hospitalet de Llobregat, Spain, 08907 | |
| GSK Investigational Site | |
| Mataro (Barcelona), Spain | |
| GSK Investigational Site | |
| Sabadell (Barcelona), Spain, 08208 | |
| GSK Investigational Site | |
| Terrassa - Barcelona, Spain, 08227 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00555139 History of Changes |
| Other Study ID Numbers: | CRH108571 |
| Study First Received: | November 5, 2007 |
| Last Updated: | October 13, 2010 |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
CRF-1 antagonists, depression, anxiety, fMRI |
|
Anxiety Disorders Phobic Disorders Mental Disorders Alprazolam Anti-Anxiety Agents Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |