Back to resultsA Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers
Primary Purpose
Depressive Disorder and Anxiety Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
single dose
Sponsored by
About this trial
This is an interventional diagnostic trial for Depressive Disorder and Anxiety Disorders focused on measuring GSK561679,, single,, dose,, lorazepam,, fMRI,, BOLD,, healthy volunteers
Eligibility 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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Active Comparator
Arm Label
placebo arm
GSK561679 arm
lorazepam arm
Arm Description
There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
Outcomes
Primary Outcome Measures
Differences in fMRI brain activation (BOLD) response in specific brain regions
Secondary Outcome Measures
Physiologic changes
Visual Analogue Scale measurement of physical reactions
Blood level of GSK561679
Vital signs & ECG recording
Lab tests for blood & urine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00513565
Brief Title
A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers
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 Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 13, 2007 (Actual)
Primary Completion Date
May 14, 2009 (Actual)
Study Completion Date
May 14, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder and Anxiety Disorders
Keywords
GSK561679,, single,, dose,, lorazepam,, fMRI,, BOLD,, healthy volunteers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo arm
Arm Type
Placebo Comparator
Arm Description
There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
Arm Title
GSK561679 arm
Arm Type
Experimental
Arm Description
There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
Arm Title
lorazepam arm
Arm Type
Active Comparator
Arm Description
There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
Intervention Type
Drug
Intervention Name(s)
single dose
Intervention Description
Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.
Primary Outcome Measure Information:
Title
Differences in fMRI brain activation (BOLD) response in specific brain regions
Time Frame
conducted the duration of the study
Secondary Outcome Measure Information:
Title
Physiologic changes
Time Frame
during & after fMRI session
Title
Visual Analogue Scale measurement of physical reactions
Time Frame
duration of study
Title
Blood level of GSK561679
Time Frame
collected during fMRI session
Title
Vital signs & ECG recording
Time Frame
duration of the study
Title
Lab tests for blood & urine
Time Frame
throughout the study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
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A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers
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