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

Depressive Disorder and Anxiety Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513565
• Other study ID #: CRS105510
• Status: Completed
• Phase: Phase 1
• First received: August 6, 2007
• Last updated: July 18, 2017
• Start date: September 13, 2007
• Est. completion date: May 14, 2009

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 14, 2009
• Est. primary completion date: May 14, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder and Anxiety Disorders

Intervention

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

Locations

Country	Name	City	State
United States	GSK Investigational Site	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in fMRI brain activation (BOLD) response in specific brain regions		conducted the duration of the study
Secondary	Physiologic changes		during & after fMRI session
Secondary	Visual Analogue Scale measurement of physical reactions		duration of study
Secondary	Blood level of GSK561679		collected during fMRI session
Secondary	Vital signs & ECG recording		duration of the study
Secondary	Lab tests for blood & urine		throughout the study

External Links

•   Results for study CRS105510 can be found on the GSK Clinical Study Register.