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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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01045083
First received: January 6, 2010
Last updated: September 19, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention Phase
Healthy Volunteer
 Drug: escitalopram
Drug: methylphenidate
Drug: RO4917523
Drug: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the ability of other behavioural paradigms/scales to detect drug effects [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To correlate the fMRI measures with the clinical/behavioral measures [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • To investigate the safety of single doses of RO4917523 in healthy volunteers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: escitalopram
Oral single dose
Other Name: Lexapro
Drug: methylphenidate
Oral single dose
Other Name: Ritalin
Drug: RO4917523
Oral single dose
Drug: placebo
Oral single dose

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045083

Locations
United States, California
La Jolla, California, United States, 92093
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01045083     History of Changes
Other Study ID Numbers: BP22651
Study First Received: January 6, 2010
Last Updated: September 19, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dexetimide
Citalopram
Methylphenidate
Serotonin Uptake Inhibitors
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on May 21, 2013