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

Hoffmann-La Roche25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Healthy Volunteer

Interventions

RO4917523DRUG

Oral single dose

escitalopramDRUG

Oral single dose

methylphenidateDRUG

Oral single dose

placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

La Jolla, California, United States

Outcomes

Primary Outcomes

To evaluate the ability of fMRI to detect and characterize the effect of the three drugs on brain activity at rest and during emotional stimuli

Time frame: 8 weeks

Secondary Outcomes

To evaluate the ability of other behavioural paradigms/scales to detect drug effects

Time frame: 8 weeks

To correlate the fMRI measures with the clinical/behavioral measures

Time frame: 8 weeks

To investigate the safety of single doses of RO4917523 in healthy volunteers

Time frame: 8 weeks

Data from ClinicalTrials.gov

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