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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Subjects; Depressive Disorder and Anxiety Disorders

Intervention: single dose (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Primary outcome: Differences in fMRI brain activation (BOLD) response in specific brain regions

Secondary outcome:

Physiologic changes

Visual Analogue Scale measurement of physical reactions

Blood level of GSK561679

Vital signs & ECG recording

Lab tests for blood & urine

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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

Locations and Contacts

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

Starting date: September 2007
Last updated: March 15, 2012

Page last updated: August 23, 2015

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