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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:
ClinicalTrials.gov Identifier:
NCT01045083
First Posted: January 8, 2010
Last Update Posted: November 2, 2016
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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: RO4917523 Drug: escitalopram Drug: methylphenidate Drug: placebo Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • To evaluate the ability of other behavioural paradigms/scales to detect drug effects [ Time Frame: 8 weeks ]
  • To correlate the fMRI measures with the clinical/behavioral measures [ Time Frame: 8 weeks ]
  • To investigate the safety of single doses of RO4917523 in healthy volunteers [ Time Frame: 8 weeks ]

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: 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

  Eligibility

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.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01045083     History of Changes
Other Study ID Numbers: BP22651
First Submitted: January 6, 2010
First Posted: January 8, 2010
Last Update Posted: November 2, 2016
Last Verified: November 2016

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