Association of Amisulpride Response in Schizophrenia With Brain Image

NCT02095938 | Unknown Phase 4

• 2 other identifiers: Sang-Hyuk LeeAMISUL06995
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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. 3.Study Design: Prospective/ Open label/ Interventional/ Controlled
4. 4.Evaluation Criteria:

Conditions

Schizophrenia; Schizophreniform Disorder

Keywords

schizophrenia; brain structure; treatment response; solian; gene; mri

Outcome Measures

Primary Outcomes (1)

• Brain structural MRI

  To show the differences of the baseline brain structures on the structural MRI between the Solian® treatment responders and the non-responders

  baseline

Secondary Outcomes (1)

• gene

  baseline

Other Outcomes (6)

• positive and negative syndrome scale

  baseline, 8 week after treatment

• scale for the assessment of negative symptoms

  baseline, 8 week after treatment

• scale for the assessment of positive symptoms

  baseline, 8 week after treatment

Study Arms (1)

Solian

EXPERIMENTAL

Amisulpride (Solian) will be orally administered once or twice daily after meal intake for 8 weeks. Patients initially will receive a low dose of amisulpride (200-400mg/day). The dosage may be adjusted to between 400 and 800mg/day according to the clinical decision by treating physician

Drug: amisulpride

Interventions

amisulpride DRUG

Amisulpride (Solian) will be orally administered once or twice daily after meal intake for 8 weeks. Patients initially will receive a low dose of amisulpride (200-400mg/day). The dosage may be adjusted to between 400 and 800mg/day according to the clinical decision by treating physician.

Also known as: Solian

Solian

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHA University: lead
• Handok Inc.: collaborator

Related Publications (11)

• Friston KJ. Theoretical neurobiology and schizophrenia. Br Med Bull. 1996 Jul;52(3):644-55. doi: 10.1093/oxfordjournals.bmb.a011573.

  PMID: 8949263 BACKGROUND

• Friston KJ, Frith CD. Schizophrenia: a disconnection syndrome? Clin Neurosci. 1995;3(2):89-97.

  PMID: 7583624 BACKGROUND

• Knochel C, O'Dwyer L, Alves G, Reinke B, Magerkurth J, Rotarska-Jagiela A, Prvulovic D, Hampel H, Linden DE, Oertel-Knochel V. Association between white matter fiber integrity and subclinical psychotic symptoms in schizophrenia patients and unaffected relatives. Schizophr Res. 2012 Sep;140(1-3):129-35. doi: 10.1016/j.schres.2012.06.001. Epub 2012 Jul 19.

  PMID: 22817874 BACKGROUND

• Konrad A, Winterer G. Disturbed structural connectivity in schizophrenia primary factor in pathology or epiphenomenon? Schizophr Bull. 2008 Jan;34(1):72-92. doi: 10.1093/schbul/sbm034. Epub 2007 May 7.

  PMID: 17485733 BACKGROUND

• Mitelman SA, Newmark RE, Torosjan Y, Chu KW, Brickman AM, Haznedar MM, Hazlett EA, Tang CY, Shihabuddin L, Buchsbaum MS. White matter fractional anisotropy and outcome in schizophrenia. Schizophr Res. 2006 Oct;87(1-3):138-59. doi: 10.1016/j.schres.2006.06.016. Epub 2006 Jul 18.

  PMID: 16854563 BACKGROUND

• Savas HA, Unal B, Erbagci H, Inaloz S, Herken H, Canan S, Gumusburun E, Zoroglu SS. Hippocampal volume in schizophrenia and its relationship with risperidone treatment: a stereological study. Neuropsychobiology. 2002;46(2):61-6. doi: 10.1159/000065413.

  PMID: 12378121 BACKGROUND

• Shenton ME, Dickey CC, Frumin M, McCarley RW. A review of MRI findings in schizophrenia. Schizophr Res. 2001 Apr 15;49(1-2):1-52. doi: 10.1016/s0920-9964(01)00163-3.

  PMID: 11343862 BACKGROUND

• Skudlarski P, Jagannathan K, Anderson K, Stevens MC, Calhoun VD, Skudlarska BA, Pearlson G. Brain connectivity is not only lower but different in schizophrenia: a combined anatomical and functional approach. Biol Psychiatry. 2010 Jul 1;68(1):61-9. doi: 10.1016/j.biopsych.2010.03.035. Epub 2010 May 23.

  PMID: 20497901 BACKGROUND

• Sporns O, Chialvo DR, Kaiser M, Hilgetag CC. Organization, development and function of complex brain networks. Trends Cogn Sci. 2004 Sep;8(9):418-25. doi: 10.1016/j.tics.2004.07.008.

  PMID: 15350243 BACKGROUND

• Molina V, Martin C, Ballesteros A, de Herrera AG, Hernandez-Tamames JA. Optimized voxel brain morphometry: association between brain volumes and the response to atypical antipsychotics. Eur Arch Psychiatry Clin Neurosci. 2011 Sep;261(6):407-16. doi: 10.1007/s00406-010-0182-2. Epub 2010 Dec 30.

  PMID: 21191610 BACKGROUND

• Zalesky A, Fornito A, Seal ML, Cocchi L, Westin CF, Bullmore ET, Egan GF, Pantelis C. Disrupted axonal fiber connectivity in schizophrenia. Biol Psychiatry. 2011 Jan 1;69(1):80-9. doi: 10.1016/j.biopsych.2010.08.022. Epub 2010 Oct 29.

  PMID: 21035793 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Amisulpride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Sang-Hyuk Lee, MD., PhD.

  Associate Professor at Bundang CHA hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 26, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 26, 2014

Record last verified: 2014-03