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Completed

NCT Number: NCT00513565

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

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.

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Key information

Conditions

Depressive Disorder and Anxiety Disorders Anxiety Disorders Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

single dose

Drug

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

Primary outcomes

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

    Time frame: conducted the duration of the study

Secondary outcomes

  1. Physiologic changes

    Time frame: during & after fMRI session

  2. Visual Analogue Scale measurement of physical reactions

    Time frame: duration of study

  3. Blood level of GSK561679

    Time frame: collected during fMRI session

  4. Vital signs & ECG recording

    Time frame: duration of the study

  5. Lab tests for blood & urine

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 8, 2007
Registry last updated
Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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