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
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT01045083
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 RO4917523 - 1 placebo - 1 methylphenidate - 1 escitalopram -
- Primary Outcome Measures
Name Time Method 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 8 weeks
- Secondary Outcome Measures
Name Time Method To evaluate the ability of other behavioural paradigms/scales to detect drug effects 8 weeks To correlate the fMRI measures with the clinical/behavioral measures 8 weeks To investigate the safety of single doses of RO4917523 in healthy volunteers 8 weeks