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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT01045083

Run by

Hoffmann-La Roche

People needed

25

Starts

2010-01-01

Expected to finish

2011-06-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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