Association of Amisulpride Response in Schizophrenia With Brain Image

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CHA University
• Collaborators: Handok Inc.; Handok Pharmaceuticals Co., Ltd.
• Treatments: Amisulpride; Sulpiride; Sultopride

Criteria

Inclusion Criteria:

• between 21 and 60 years of age

• diagnosed with schizophrenia, based on the Structured Clinical Interview for DSM-IV(SCID)

• first or second episode of schizophrenia patient

• the presence of positive or negative symptoms or both, resulting in illness of at least mild severity (≥3 on the Clinical Global Impression (CGI) severity scale

Exclusion Criteria:

• evidence of organic mental disorder or mental retardation

• severe drug or alcohol dependence that required inpatient treatment and/or detoxification

• other conditions, such as a serious medical condition, a history of bipolar or schizoaffective disorder, suicidality, possibility of pregnancy, lactation, or inability/unwillingness to use contraception

• contraindicated with Solian® by the product label