A Study of the Ability of Functional Magnetic Resonance Imaging (fMRI) to Detect and Characterize the Effects of Two Marketed Centrally Active Drugs, Placebo, and RO4917523 in Healthy Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:8/3/2016
Start Date:January 2010
End Date:June 2011

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Randomized, Observer-blind, Placebo-controlled, Four-way Cross-over Study to Study the Ability of Functional Magnetic Resonance Imaging (fMRI) of the Brain to Detect and Characterize the Effects of Single Doses of a Selective Serotonin Reuptake Inhibitor (Escitalopram [Lexapro]), a Dopamine

This is an exploratory study to evaluate the usefulness of fMRI as a biomarker to
characterize the response to three centrally active drugs and placebo.


Inclusion Criteria:

- Adult patients, 18 to 45 years of age

- In good general health

- Weight of ≥120 lbs (55 kg) and a body mass index (BMI) between 18 to 30kg/m²

- Males and females with reproductive potential: willing to use a reliable method of
contraception

Exclusion Criteria:

- Evidence of clinically significant disease

- Medical or surgical condition that could alter the absorption, metabolism, or
elimination of drugs

- Family history of sudden death or ventricular arrhythmia

- History of any psychiatric disorder and/or marked anxiety

- History of glaucoma

- History (including family) of motor tic or diagnosis of Tourette's syndrome

- Active suicide ideation

- Contraindication to MRI
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