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 |
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.
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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