NCT01972711

Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the effects of a single dose of SEP-363856 in healthy male and female volunteers with high or low schizotype characteristics.

Detailed description

The study is a randomized, double-blind, placebo-controlled functional magnetic resonance imaging (fMRI) study of the effects of a single dose of SEP-363856 and amisulpride on blood oxygen level dependent (BOLD) signal in healthy male and female volunteers with high or low schizotype characteristics.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	SEP-363856	SEP-36385625 as a single oral dose of 50 mg
DRUG	Amisulpride	Amisulpride as a single oral dose of 400 mg
DRUG	Placebo	single oral dose placebo

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2013-10-30
• Last updated: 2024-06-26

Locations

2 sites across 1 country: United Kingdom