The effects of SEP-363858 on high or low schizotype characteristics
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled, single-dose, study of the effects of SEP 363856 and Amisulpride on bold=FMRI signal in healthy male and female volunteers with high or low schizotype characteristics.
IRAS ID
138048
Contact name
J F W Deakin
Contact email
Sponsor organisation
Sunovion Pharmaceuticals Inc
Eudract number
2013-003801-24
Research summary
The study is looking at whether a single dose of SEP-363856 and amisulpride will lead to changes in neural activity (that is the Blood Oxygen Level Dependent, BOLD signal) in individuals with high or low schizotype characteristics. This activity will be measured using functional magnetic resonance imaging (fMRI) while participants are performing tasks that use memory and learning.
Individuals will be recruited from the general population and will initially be asked to complete an online questionnaire to determine their schizotypy score. Suitability for the next stage of the study will be based on the responses to the online questionnaire. Telephone interviews will then be conducted with individuals who have schizotypy scores in the required ranges to assess whether they should be invited to attend the research centre for a screening visit. Screening visits (visit 1) will then be carried out to determine whether the participant is eligible to enter the study. If participants remain suitable they will be invited to attend an assessment day (visit 2 - within 28 days of their initial visit) in which they will either take SEP-363856 (a new medication that is not yet on the market), Amisulpiride (a medication that is already marketed and prescribed by doctors) or a dummy drug (placebo).
Having received the medication, participants will then undergo an fMRI and be asked to perform computer-based tasks (both inside the scanner and outside of the scanner) as well as to complete questionnaires. Participants will then return for a final visit (within 7 to 14 days of Visit 2) to undergo a final medical assessment and completion of questionnaires.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
13/NW/0727
Date of REC Opinion
21 Jan 2014
REC opinion
Further Information Favourable Opinion