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

GlaxoSmithKline22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Depressive Disorder and Anxiety Disorders

Interventions

single doseDRUG

Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

La Jolla, California, United States

Outcomes

Primary Outcomes

Differences in fMRI brain activation (BOLD) response in specific brain regions

Time frame: conducted the duration of the study

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.