A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00513565

Purpose

This study will be conducted in healthy volunteers to investigate the effect of single dose GSK561679 on the changes of brain activation, as it compares to an active comparator, lorazepam.

Condition	Intervention	Phase
Healthy Subjects Depressive Disorder and Anxiety Disorders	Drug: single dose	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic
Official Title:	A Randomised, Placebo-controlled, Double-dummy, Crossover Design Study to Investigate the Changes of fMRI BOLD Activation Induced by Emotional Activation Paradigms Following Single Doses of GSK561679 and Lorazepam (Comparator) in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression

Drug Information available for: Lorazepam

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Differences in fMRI brain activation (BOLD) response in specific brain regions [ Time Frame: conducted the duration of the study ]

Secondary Outcome Measures:

Physiologic changes [ Time Frame: during & after fMRI session ]
Visual Analogue Scale measurement of physical reactions [ Time Frame: duration of study ]
Blood level of GSK561679 [ Time Frame: collected during fMRI session ]
Vital signs & ECG recording [ Time Frame: duration of the study ]
Lab tests for blood & urine [ Time Frame: throughout the study ]

Enrollment:	22
Study Start Date:	September 2007
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: placebo arm There are single dose treatment arms of GSK561679, lorazepam as well as placebo.	Drug: single dose Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.
Experimental: GSK561679 arm There are single dose treatment arms of GSK561679, lorazepam as well as placebo.	Drug: single dose Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.
Active Comparator: lorazepam arm There are single dose treatment arms of GSK561679, lorazepam as well as placebo.	Drug: single dose Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy males
Non-smokers
Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-29.9 kg/m2
Normal ECG.

Exclusion Criteria:

Any serious medical disorder or condition.
Any history of an endocrine disorder.
Any clinically significant laboratory abnormality.
History of psychiatric illness.
Any history of suicidal attempts or behavior.
History or current diagnosis of acute narrow angle glaucoma.
Left handed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513565

Locations

United States, California
GSK Investigational Site
La Jolla, California, United States, 92037

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00513565 History of Changes
Other Study ID Numbers:	CRS 105510
Study First Received:	August 6, 2007
Last Updated:	August 30, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

GSK561679,
single,
dose,
lorazepam,

fMRI,
BOLD,
healthy volunteers

Additional relevant MeSH terms:

Anxiety Disorders
Depressive Disorder
Depression
Mental Disorders
Mood Disorders
Behavioral Symptoms
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

ClinicalTrials.gov processed this record on February 09, 2012