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

NCT ID: NCT00513565

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-13

Study Completion Date

2009-05-14

Brief Summary

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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.

Detailed Description

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Conditions

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Depressive Disorder and Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo arm

There are single dose treatment arms of GSK561679, lorazepam as well as placebo.

Group Type PLACEBO_COMPARATOR

single dose

Intervention Type DRUG

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

GSK561679 arm

There are single dose treatment arms of GSK561679, lorazepam as well as placebo.

Group Type EXPERIMENTAL

single dose

Intervention Type DRUG

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

lorazepam arm

There are single dose treatment arms of GSK561679, lorazepam as well as placebo.

Group Type ACTIVE_COMPARATOR

single dose

Intervention Type DRUG

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

Interventions

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single dose

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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CRS105510

Identifier Type: -

Identifier Source: org_study_id

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