Association of Amisulpride Response in Schizophrenia With Brain Image
Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
1. Study rationale - Nielsen et al reported that after 6 weeks of amisulpride treatment,
patients with schizophrenia showed an increase in the anticipation-related functional
MRI signal. This suggested that amisulpride could affect the brain structures and that
responses to amisulpride could be associated by the brain structures as seen previous
studies about treatment response to antipsychotics and brain structures. But to date, no
study has examined the impact of brain structure alterations on amisulpride treatment
for schizophrenia and its potential clinical significance.
2. Study Objectives 2-1. Primary: To show the differences of the baseline brain structures
on the structural MRI between the Solian® treatment responders and the non-responders
2-2. Secondary: To show the differences of the baseline polymorphisms of COMT and BDNF
with molecular genetic analysis between the Solian® treatment responders and the
non-responders responder defined by PANSS. To find out the correlates of baseline brain
structures with symptom severity of schizophrenia at baseline; symptom severity defined
by CGI-S and PANSS. To assess psychotic symptom improvement after 8th week of Solian®
treatment using PANSS, SANS, SAPS and CGI. To assess safety after 8th week of Solian®
treatment with Barnes Akathisia Scale, Simpson-Angus scale and vital signs. To report
all serious adverse event within 24hrs regardless of relationship to investigational
product.
3. Study Design: Prospective/ Open label/ Interventional/ Controlled
4. Evaluation Criteria:
5-1. Primary endpoints: Brain structures on the structural MRI will be observed before the
treatment starts. Based on the clinical response after treatment, patients will be divided in
the two different groups as follow and their baseline brain structure of will be compared.
Treatment responders and non-responders.
5-2. Secondary endpoints: The relationship of baseline brain structures with symptom severity
of schizophrenia. Severity will be determined by CGI-S and PANSS at baseline. The differences
of the polymorphisms of COMT and BDNF with molecular genetic analysis using patients'
peripheral blood, especially leukocytes, between the treatment responders and the
non-responders. Efficacy - PANSS, SANS, SAPS, CGI. Safety - Barnes akathisia scale,
Simpson-Angus scale, Vital signs