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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

Randomized, Observer-blind, Placebo-controlled, Four-way Cross-over Study to Study the Ability of Functional Magnetic Resonance Imaging (fMRI) of the Brain to Detect and Characterize the Effects of Single Doses of a Selective Serotonin Reuptake Inhibitor (Escitalopram [Lexapro]), a Dopamine

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01045083
Enrollment
25
Registered
2010-01-08
Start date
2010-01-31
Completion date
2011-06-30
Last updated
2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGRO4917523

Oral single dose

DRUGescitalopram

Oral single dose

DRUGmethylphenidate

Oral single dose

DRUGplacebo

Oral single dose

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
To evaluate the ability of fMRI to detect and characterize the effect of the three drugs on brain activity at rest and during emotional stimuli8 weeks

Secondary

MeasureTime frame
To evaluate the ability of other behavioural paradigms/scales to detect drug effects8 weeks
To correlate the fMRI measures with the clinical/behavioral measures8 weeks
To investigate the safety of single doses of RO4917523 in healthy volunteers8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026