Last updated: 11/04/2018 06:05:17

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

GSK study ID
CRS105510
See study documents
Clinicaltrials.gov ID
NCT00513565
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Diagnostic
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: conducted the duration of the study

Secondary outcomes:

Physiologic changes

Timeframe: during & after fMRI session

Visual Analogue Scale measurement of physical reactions

Timeframe: duration of study

Blood level of GSK561679

Timeframe: collected during fMRI session

Vital signs & ECG recording

Timeframe: duration of the study

Lab tests for blood & urine

Timeframe: throughout the study

Interventions:
Drug: single dose
Enrollment:
22
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Depressive Disorder and Anxiety Disorders
Product
verucerfont
Collaborators
Not applicable
Study date(s)
September 2007 to May 2009
Type
Interventional
Phase
1

Participation criteria

Sex
Female
Age
18 - 50 years
Accepts healthy volunteers
Yes
  • Healthy males
  • Non-smokers
  • Any serious medical disorder or condition.
  • Any history of an endocrine disorder.
Inclusion and exclusion 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

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
La Jolla, California, United States, 92037
Status
Study Complete
Contact us

Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-14-05

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
Results for study CRS105510 can be found on the GSK Clinical Study Register.
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Access to clinical trial data by researchers
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