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

Phase 1

Completed

• Conditions: Depressive Disorder and Anxiety Disorders
• Interventions: Drug: single dose

• Registration Number: NCT00513565
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-06
• Study First Submitted QC: 2007-08-06
• Study First Posted: 2007-08-08
• Study Start: 2007-09-13
• Primary Completion: 2009-05-14
• Study Completion: 2009-05-14
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GSK561679 arm	single dose	There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
placebo arm	single dose	There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
lorazepam arm	single dose	There are single dose treatment arms of GSK561679, lorazepam as well as placebo.

Primary Outcome Measures

Name	Time	Method
Differences in fMRI brain activation (BOLD) response in specific brain regions	conducted the duration of the study

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 La Jolla, California, United States