Schizophrenia Clinical Trial
— ARBOfficial title:
Association of the Amisulpride Treatment Response in Patients With Schizophrenia With the Findings of Brain Structural Magnetic Resonance Imaging
Verified date | March 2014 |
Source | CHA University |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Korea Food and Drug Administration (KFDA) |
Study type | Interventional |
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
Status | Enrolling by invitation |
Enrollment | 20 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 60 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
CHA University | Handok Pharmaceuticals Co., Ltd. |
Friston KJ, Frith CD. Schizophrenia: a disconnection syndrome? Clin Neurosci. 1995;3(2):89-97. Review. — View Citation
Friston KJ. Theoretical neurobiology and schizophrenia. Br Med Bull. 1996 Jul;52(3):644-55. — View Citation
Knöchel C, O'Dwyer L, Alves G, Reinke B, Magerkurth J, Rotarska-Jagiela A, Prvulovic D, Hampel H, Linden DE, Oertel-Knöchel 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. Erratum in: Schizophr Res. 2012 Dec;142(1-3):250. — View Citation
Konrad A, Winterer G. Disturbed structural connectivity in schizophrenia primary factor in pathology or epiphenomenon? Schizophr Bull. 2008 Jan;34(1):72-92. Epub 2007 May 7. Review. — View Citation
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. Epub 2006 Jul 18. — View Citation
Molina V, Martín C, Ballesteros A, de Herrera AG, Hernández-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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | positive and negative syndrome scale | To assess psychotic symptom improvement after 8th week of Solian® treatment using positive and negative syndrome scale (PANSS), scale for the assessment of negative symptoms (SANS), scale for the assessment of positive symptoms (SAPS) and clinical global impression scale (CGI) | baseline, 8 week after treatment | No |
Other | scale for the assessment of negative symptoms | To assess psychotic symptom improvement after 8th week of Solian® treatment using positive and negative syndrome scale (PANSS), scale for the assessment of negative symptoms (SANS), scale for the assessment of positive symptoms (SAPS) and clinical global impression scale (CGI) | baseline, 8 week after treatment | No |
Other | scale for the assessment of positive symptoms | To assess psychotic symptom improvement after 8th week of Solian® treatment using positive and negative syndrome scale (PANSS), scale for the assessment of negative symptoms (SANS), scale for the assessment of positive symptoms (SAPS) and clinical global impression scale (CGI) | baseline, 8 week after treatment | No |
Other | clinical global impression scale | To assess psychotic symptom improvement after 8th week of Solian® treatment using positive and negative syndrome scale (PANSS), scale for the assessment of negative symptoms (SANS), scale for the assessment of positive symptoms (SAPS) and clinical global impression scale (CGI) | baseline, 8 week after treatment | No |
Other | Barnes Akathisia Scale | To assess safety after 8th week of Solian® treatment with Barnes Akathisia Scale, Simpson-Angus scale and vital signs | baseline, 8 week after treatment | No |
Other | Simpson-Angus scale and vital signs | To assess safety after 8th week of Solian® treatment with Barnes Akathisia Scale, Simpson-Angus scale and vital signs | baseline, 8 week after treatment | No |
Primary | 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 | No |
Secondary | gene | 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 | baseline | No |
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