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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01045083
Recruitment Status : Completed
First Posted : January 8, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO4917523 Drug: escitalopram Drug: methylphenidate Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official 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
Study Start Date : January 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: 1 Drug: RO4917523
Oral single dose

Drug: escitalopram
Oral single dose
Other Name: Lexapro

Drug: methylphenidate
Oral single dose
Other Name: Ritalin

Drug: placebo
Oral single dose

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01045083

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United States, California
La Jolla, California, United States, 92093
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT01045083    
Other Study ID Numbers: BP22651
First Posted: January 8, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Dopamine Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Stimulants
Dopamine Agents