A study of risperidone, olanzapine and haloperidol using fMRI; ver 1
Research type
Research Study
Full title
Methodologic study to evaluate brain functional magnetic resonance imaging (fMRI) signals as pharmacodynamic parameters after oral administration of risperidone, olanzapine, haloperidol or placebo in healthy subjects. HMR code 13-006.
IRAS ID
135274
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Research summary
Risperidone, olanzapine and haloperidol are existing medicines for illnesses that affect the way you think, feel or behave, such as schizophrenia and bipolar disorder.
We’re doing this study to test whether fMRI (functional magnetic resonance imaging) is a useful way of measuring the effects of medicines on brain activity.
We’ll do the study in 42 healthy men, aged between 18 and 45, in 2 groups of 21 volunteers, called Groups A and B.
Each volunteer will have 3 study sessions. In each session, they’ll take a single dose of one of the study medicines, or dummy medicine, and have 1 fMRI scan.
Group A will take each of the following doses: 0.5 mg risperidone, 2 mg risperidone, and dummy medicine. Group B will take each of the following doses: 3 mg haloperidol, 7.5 mg olanzapine and dummy medicine. A computer will decide in which session they take each medicine.
Participants will take up to 13 weeks to finish the study. They’ll make up to 2 outpatient visits, and stay on the ward for 3 nights.
A pharmaceutical company, F. Hoffman-La Roche Ltd, is funding the study.
The study will take place at 1 research centre in London. The fMRI scans will be done at another site, the Institute of Psychiatry in London. We’ll recruit healthy participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.
REC name
London - Brent Research Ethics Committee
REC reference
13/LO/1183
Date of REC Opinion
28 Aug 2013
REC opinion
Favourable Opinion