Overview

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
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Citalopram
Dexetimide
Methylphenidate
Serotonin Uptake Inhibitors
Criteria
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