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Association of Amisulpride Response in Schizophrenia With Brain Image (ARB)

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ClinicalTrials.gov Identifier: NCT02095938
Recruitment Status : Unknown
Verified March 2014 by Sang-Hyuk Lee, CHA University.
Recruitment status was:  Enrolling by invitation
First Posted : March 26, 2014
Last Update Posted : March 26, 2014
Sponsor:
Collaborator:
Handok Inc.
Information provided by (Responsible Party):
Sang-Hyuk Lee, CHA University

Brief 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


Condition or disease Intervention/treatment Phase
Schizophrenia Schizophreniform Disorder Drug: amisulpride Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Association of the Amisulpride Treatment Response in Patients With Schizophrenia With the Findings of Brain Structural Magnetic Resonance Imaging
Study Start Date : January 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Solian
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
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.
Other Name: Solian




Primary Outcome Measures :
  1. Brain structural MRI [ Time Frame: baseline ]
    To show the differences of the baseline brain structures on the structural MRI between the Solian® treatment responders and the non-responders


Secondary Outcome Measures :
  1. gene [ Time Frame: baseline ]
    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


Other Outcome Measures:
  1. positive and negative syndrome scale [ Time Frame: baseline, 8 week after treatment ]
    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)

  2. scale for the assessment of negative symptoms [ Time Frame: baseline, 8 week after treatment ]
    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)

  3. scale for the assessment of positive symptoms [ Time Frame: baseline, 8 week after treatment ]
    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)

  4. clinical global impression scale [ Time Frame: baseline, 8 week after treatment ]
    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)

  5. Barnes Akathisia Scale [ Time Frame: baseline, 8 week after treatment ]
    To assess safety after 8th week of Solian® treatment with Barnes Akathisia Scale, Simpson-Angus scale and vital signs

  6. Simpson-Angus scale and vital signs [ Time Frame: baseline, 8 week after treatment ]
    To assess safety after 8th week of Solian® treatment with Barnes Akathisia Scale, Simpson-Angus scale and vital signs



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095938


Sponsors and Collaborators
CHA University
Handok Inc.
Investigators
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Principal Investigator: Sang-Hyuk Lee, MD., PhD. Associate Professor at Bundang CHA hospital

Publications:

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Responsible Party: Sang-Hyuk Lee, Associate Professor, CHA University
ClinicalTrials.gov Identifier: NCT02095938    
Other Study ID Numbers: Sang-Hyuk Lee
AMISUL06995 ( Other Grant/Funding Number: Handok Inc. )
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014
Keywords provided by Sang-Hyuk Lee, CHA University:
schizophrenia
brain structure
treatment response
solian
gene
mri
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Amisulpride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents