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
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 6, 2010
CompletedFirst Posted
Study publicly available on registry
January 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedNovember 2, 2016
November 1, 2016
1.4 years
January 6, 2010
November 1, 2016
Conditions
Outcome Measures
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
8 weeks
Secondary Outcomes (3)
To evaluate the ability of other behavioural paradigms/scales to detect drug effects
8 weeks
To correlate the fMRI measures with the clinical/behavioral measures
8 weeks
To investigate the safety of single doses of RO4917523 in healthy volunteers
8 weeks
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
La Jolla, California, 92093, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2010
First Posted
January 8, 2010
Study Start
January 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
November 2, 2016
Record last verified: 2016-11