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

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ClinicalTrials.gov Identifier: NCT00513565
Recruitment Status : Completed
First Posted : August 8, 2007
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder and Anxiety Disorders Drug: single dose Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
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
Actual Study Start Date : September 13, 2007
Primary Completion Date : May 14, 2009
Study Completion Date : May 14, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Lorazepam
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo arm
There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
Drug: single dose
Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.
Experimental: GSK561679 arm
There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
Drug: single dose
Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.
Active Comparator: lorazepam arm
There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
Drug: single dose
Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.


Outcome Measures

Primary Outcome Measures :
  1. Differences in fMRI brain activation (BOLD) response in specific brain regions [ Time Frame: conducted the duration of the study ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00513565


Locations
United States, California
GSK Investigational Site
La Jolla, California, United States, 92037
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00513565     History of Changes
Other Study ID Numbers: CRS105510
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by GlaxoSmithKline:
GSK561679,
single,
dose,
lorazepam,
fMRI,
BOLD,
healthy volunteers

Additional relevant MeSH terms:
Depressive Disorder
Depression
Anxiety Disorders
Mood Disorders
Mental Disorders
Behavioral Symptoms
Lorazepam
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action