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Completed

NCT Number: NCT01045083

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

La Jolla, California, 92093, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO4917523

Drug

Oral single dose

Escitalopram

Drug

Oral single dose

Other names: Lexapro

Methylphenidate

Drug

Oral single dose

Other names: Ritalin

Placebo

Drug

Oral single dose

Primary outcomes

  1. 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

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

    Time frame: 8 weeks

  2. To correlate the fMRI measures with the clinical/behavioral measures

    Time frame: 8 weeks

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

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 8, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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