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

NCT ID: NCT01045083

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

RO4917523

Intervention Type DRUG

Oral single dose

escitalopram

Intervention Type DRUG

Oral single dose

methylphenidate

Intervention Type DRUG

Oral single dose

placebo

Intervention Type DRUG

Oral single dose

Interventions

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RO4917523

Oral single dose

Intervention Type DRUG

escitalopram

Oral single dose

Intervention Type DRUG

methylphenidate

Oral single dose

Intervention Type DRUG

placebo

Oral single dose

Intervention Type DRUG

Other Intervention Names

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Lexapro Ritalin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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La Jolla, California, United States

Site Status

Countries

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United States

Other Identifiers

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BP22651

Identifier Type: -

Identifier Source: org_study_id