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
Study complete
Study complete
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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    Study complete
    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

    Participate in clinical trial
    Additional information
    Results for study CRS105510 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
    Visit website