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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: methylphenidate; Drug: escitalopram; Drug: RO4917523; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01045083

BP22651

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 1 patient group

1

Experimental group

Treatment:

Drug: placebo

Drug: RO4917523

Drug: escitalopram

Drug: methylphenidate