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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045083
• Other study ID #: BP22651
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2010
• Last updated: November 1, 2016
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4917523
Oral single dose
• escitalopram
Oral single dose
• methylphenidate
Oral single dose
• placebo
Oral single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate the ability of other behavioural paradigms/scales to detect drug effects		8 weeks	No
Secondary	To correlate the fMRI measures with the clinical/behavioral measures		8 weeks	No
Secondary	To investigate the safety of single doses of RO4917523 in healthy volunteers		8 weeks	No