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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

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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

25 participants in 1 patient group

1
Experimental group
Treatment:
Drug: placebo
Drug: RO4917523
Drug: escitalopram
Drug: methylphenidate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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