SchizophreniaPhase 4ARBNCT02095938
Association of Amisulpride Response in Schizophrenia With Brain Image
A Phase 4 study testing amisulpride in people with Schizophrenia and Schizophreniform Disorder, run by CHA University.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorder
- What is being tested?
- amisulpride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Association of the Amisulpride Treatment Response in Patients With Schizophrenia With the Findings of Brain Structural Magnetic Resonance Imaging
- 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.
- 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.
- Study Design: Prospective/ Open label/ Interventional/ Controlled
- 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
Read the detailed description
- Study rationale 1-1.
- Predicting the treatment response of antipsychotic drug in schizophrenia patients has been an issue in psychiatry. However, it is not clear if the findings of structural magnetic resonance imaging (MRI) such as brain gray matter volumes and white matter connectivities, are related to the treatment response of antipsychotic drugs.
- The cognitive and behavioural symptoms of patients with schizophrenia are hypothesized to involve a disruption of neuronal interactions resulting in dysfunctional cognitive integration (Friston et al., 1995, 1996). This hypothesis is supported by reports about a decrease in white matter anatomic connections (Mitelman et al. 2006; Skudlarski et al. 2010; Zalesky et al. 2011) and brain structure alterations, especially decrease in volumes of specific brain regions for patients with schizophrenia. Several studies of brain connectivity have shown that functional connectivity depends strongly on the underlying anatomic structure (Sporns O et al. 2004). At the anatomic level, the pathology of schizophrenia has been related to a wide range of anatomic abnormalities, including ventricular enlargement, associated with anomalous neurodevelopment or neurodegenerative alterations (Shenton ME et al 2001). And schizophrenia is likely to be the result of both general and specific localized changes in both grey and white matter (Knochel C et al. 2012; Konrad A et al. 2008). Savas HA et al. found that responders to risperidone had greater hippocampal volumes than patients who failed to respond to risperidone (Savas HA et al., 2002). Vicente M et al. found an inverse association between striatal size and the degree of clinical improvement, and a direct association between the degree of insular volume deficit and its improvement. The non-responders to risperidone or olanzapine showed a significant decrease in their left rectal gyrus as compared with the responder group. (Vicente M et al., 2010).
- Nielsen et al reported that after 6 weeks of amisulpride treatment, patients with schizophrenia showed an increase in the anticipation-related functional MRI signal (Nielsen et al., 2012). 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..
- Study type: Clinical Study Phase IV
- Number of centers: a single center in Korea
- Number of subjects: N= 20 patients
- Study duration and dates (format date : dd/mmm/yyyy) 5-1. Protocol planned date: 01/Apr/2013 5-2. First patient In: 01/Nov/2013 5-3. Last patient In: 01/Oct/2015 5-4. Last patient Out: 01/Dec/2015 5-5. Estimated enrollment duration: 2 years 5-6. Estimated average treatment duration: 8 weeks 5-7. Database lock planned date: 15/Dec/2015 5-8. Estimated Report/Publication date: 31/Dec/2015
- Indication: Schizophrenia
- Study Objectives (Primary / Most Important Secondary): 7-1. Primary: To show the differences of the baseline brain structures on the structural MRI between the Solian® treatment responders and the non-responders 7-2. 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 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)
- 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 (SAE) within 24hrs regardless of relationship to investigational product. SAE or expedited reports are completed including: death, Requiring/prolonging hospitalization, Congenital anomaly/Birth defect, Life-threatening, Persistent/significant disability/incapacity, A procedure result only if symptomatic, considered by the investigator as clinically significant or meaningful or leading to permanent investigational product discontinuation or requiring corrective treatment, A symptomatic overdose, A pregnancy, AESI (adverse event special interest with immediate notification) in AEs( serious or non-serious) that need to be monitored, documented, and managed in a pre-specified manner described in the protocol.
- Inclusion Criteria: 8-1. between 21 and 60 years of age 8-2. diagnosed with schizophrenia, based on the Structured Clinical Interview for DSM-IV(SCID) 8-3. first or second episode of schizophrenia patient 8-4. 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: 9-1. evidence of organic mental disorder or mental retardation 9-2. severe drug or alcohol dependence that required inpatient treatment and/or detoxification 9-3. 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 9-4. contraindicated with Solian® by the product label
- Study Design: Prospective/ Open label/ Interventional/ Controlled
- Treatments: 11-1. Study medication - Solian® and there is no comparator medication. 11-2. 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. 11-3. For efficacy assessment, psychotic symptoms will be assessed on baseline and 8th week by psychiatrists with 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). 11-4. For safety assessment, Barnes Akathisia Scale, Simpson-Angus scale and vital signs will be assessed on 8th week of treatment. 11-5. Treatment responders will be defined as patients whose PANSS score reduction by 30% or more and patients whose PANSS score decrease by less than 30% will be assigned to non-responder group. 11-6. The investigators will evaluate the differences of gray matter volume and white matter connectivity between responders and non-responders to amisulpride with images from brain 3T magnetic resonance imaging (MRI) using voxel-based morphometry (VBM) and tract-based spatial statistics (TBSS) at baseline. To examine a possible association between a specific brain region and response to amisulpride, the investigators will use methods based on the definition of regions of interest (ROIs). 11-7. The investigators will evaluate the polymorphisms of COMT and BDNF with molecular genetic analysis using patients' peripheral blood, especially leukocytes at baseline. One-way analysis of variance (ANOVA) will be used to assess variations in clinical symptoms and cognitive function according to COMT and BDNF polymorphisms.
- Evaluation Criteria: 12-1 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; Treatment response will be defined as patients whose PANSS score reduce by 30% or more and non-responder as patients whose PANSS score decrease by less than 30% at 8 weeks from baseline. 12-2 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 on baseline and 8th week
- Safety : Barnes akathisia scale, Simpson-Angus scale, Vital signs at 8th week
- Study Budget 13-1. Total Study Cost (euro): 13,848 euro (1 EUR = 1445 KRW) 13-2. Y (year of Study Outline approval): 5,539 EUR 13-3. Y+1: 5,539 EUR 13-4. Beyond Y+1: 2,770 EUR
- Conditions
- Schizophrenia, Schizophreniform Disorder
- Being tested
- amisulpride
- Keywords
- schizophrenia, brain structure, treatment response, solian, gene, mri
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amisulprideDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: amisulpride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (1)
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Collaborators
- Handok Inc.
- Responsible party
- Principal investigator, Sang-Hyuk Lee, CHA University
- Investigators
- Sang-Hyuk Lee, MD., PhD., Principal investigator, Associate Professor at Bundang CHA hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095938
- Sponsor's protocol ID
- Sang-Hyuk Lee
- Other IDs
- AMISUL06995
- Acronym
- ARB
- Status last verified
- Mar 2014
- First submitted
- 20 Mar 2014
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Friston KJ. Theoretical neurobiology and schizophrenia. Br Med Bull. 1996 Jul;52(3):644-55. doi: 10.1093/oxfordjournals.bmb.a011573.
PubMed 8949263Friston KJ, Frith CD. Schizophrenia: a disconnection syndrome? Clin Neurosci. 1995;3(2):89-97.
PubMed 7583624Knochel 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.
PubMed 22817874Konrad 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.
PubMed 17485733Mitelman 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.
PubMed 16854563Savas 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.
PubMed 12378121Shenton 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.
PubMed 11343862Skudlarski 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.
PubMed 20497901Sporns 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.
PubMed 15350243Molina 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.
PubMed 21191610Zalesky 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.
PubMed 21035793
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of the Amisulpride Treatment Response in Patients With Schizophrenia With the Findings of Brain Structural Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02095938
- Acronym / sponsor ID
- ARB / Sang-Hyuk Lee
- Conditions
- Schizophrenia, Schizophreniform Disorder
- Keywords
- schizophrenia, brain structure, treatment response, solian, gene, mri
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Collaborators
- Handok Inc.
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- Study Design: Prospective/ Open label/ Interventional/ Controlled
- 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
Detailed description
- Study rationale 1-1.
- Predicting the treatment response of antipsychotic drug in schizophrenia patients has been an issue in psychiatry. However, it is not clear if the findings of structural magnetic resonance imaging (MRI) such as brain gray matter volumes and white matter connectivities, are related to the treatment response of antipsychotic drugs.
- The cognitive and behavioural symptoms of patients with schizophrenia are hypothesized to involve a disruption of neuronal interactions resulting in dysfunctional cognitive integration (Friston et al., 1995, 1996). This hypothesis is supported by reports about a decrease in white matter anatomic connections (Mitelman et al. 2006; Skudlarski et al. 2010; Zalesky et al. 2011) and brain structure alterations, especially decrease in volumes of specific brain regions for patients with schizophrenia. Several studies of brain connectivity have shown that functional connectivity depends strongly on the underlying anatomic structure (Sporns O et al. 2004). At the anatomic level, the pathology of schizophrenia has been related to a wide range of anatomic abnormalities, including ventricular enlargement, associated with anomalous neurodevelopment or neurodegenerative alterations (Shenton ME et al 2001). And schizophrenia is likely to be the result of both general and specific localized changes in both grey and white matter (Knochel C et al. 2012; Konrad A et al. 2008). Savas HA et al. found that responders to risperidone had greater hippocampal volumes than patients who failed to respond to risperidone (Savas HA et al., 2002). Vicente M et al. found an inverse association between striatal size and the degree of clinical improvement, and a direct association between the degree of insular volume deficit and its improvement. The non-responders to risperidone or olanzapine showed a significant decrease in their left rectal gyrus as compared with the responder group. (Vicente M et al., 2010).
- Nielsen et al reported that after 6 weeks of amisulpride treatment, patients with schizophrenia showed an increase in the anticipation-related functional MRI signal (Nielsen et al., 2012). 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..
- Study type: Clinical Study Phase IV
- Number of centers: a single center in Korea
- Number of subjects: N= 20 patients
- Study duration and dates (format date : dd/mmm/yyyy) 5-1. Protocol planned date: 01/Apr/2013 5-2. First patient In: 01/Nov/2013 5-3. Last patient In: 01/Oct/2015 5-4. Last patient Out: 01/Dec/2015 5-5. Estimated enrollment duration: 2 years 5-6. Estimated average treatment duration: 8 weeks 5-7. Database lock planned date: 15/Dec/2015 5-8. Estimated Report/Publication date: 31/Dec/2015
- Indication: Schizophrenia
- Study Objectives (Primary / Most Important Secondary): 7-1. Primary: To show the differences of the baseline brain structures on the structural MRI between the Solian® treatment responders and the non-responders 7-2. 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 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)
- 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 (SAE) within 24hrs regardless of relationship to investigational product. SAE or expedited reports are completed including: death, Requiring/prolonging hospitalization, Congenital anomaly/Birth defect, Life-threatening, Persistent/significant disability/incapacity, A procedure result only if symptomatic, considered by the investigator as clinically significant or meaningful or leading to permanent investigational product discontinuation or requiring corrective treatment, A symptomatic overdose, A pregnancy, AESI (adverse event special interest with immediate notification) in AEs( serious or non-serious) that need to be monitored, documented, and managed in a pre-specified manner described in the protocol.
- Inclusion Criteria: 8-1. between 21 and 60 years of age 8-2. diagnosed with schizophrenia, based on the Structured Clinical Interview for DSM-IV(SCID) 8-3. first or second episode of schizophrenia patient 8-4. 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: 9-1. evidence of organic mental disorder or mental retardation 9-2. severe drug or alcohol dependence that required inpatient treatment and/or detoxification 9-3. 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 9-4. contraindicated with Solian® by the product label
- Study Design: Prospective/ Open label/ Interventional/ Controlled
- Treatments: 11-1. Study medication - Solian® and there is no comparator medication. 11-2. 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. 11-3. For efficacy assessment, psychotic symptoms will be assessed on baseline and 8th week by psychiatrists with 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). 11-4. For safety assessment, Barnes Akathisia Scale, Simpson-Angus scale and vital signs will be assessed on 8th week of treatment. 11-5. Treatment responders will be defined as patients whose PANSS score reduction by 30% or more and patients whose PANSS score decrease by less than 30% will be assigned to non-responder group. 11-6. The investigators will evaluate the differences of gray matter volume and white matter connectivity between responders and non-responders to amisulpride with images from brain 3T magnetic resonance imaging (MRI) using voxel-based morphometry (VBM) and tract-based spatial statistics (TBSS) at baseline. To examine a possible association between a specific brain region and response to amisulpride, the investigators will use methods based on the definition of regions of interest (ROIs). 11-7. The investigators will evaluate the polymorphisms of COMT and BDNF with molecular genetic analysis using patients' peripheral blood, especially leukocytes at baseline. One-way analysis of variance (ANOVA) will be used to assess variations in clinical symptoms and cognitive function according to COMT and BDNF polymorphisms.
- Evaluation Criteria: 12-1 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; Treatment response will be defined as patients whose PANSS score reduce by 30% or more and non-responder as patients whose PANSS score decrease by less than 30% at 8 weeks from baseline. 12-2 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 on baseline and 8th week
- Safety : Barnes akathisia scale, Simpson-Angus scale, Vital signs at 8th week
- Study Budget 13-1. Total Study Cost (euro): 13,848 euro (1 EUR = 1445 KRW) 13-2. Y (year of Study Outline approval): 5,539 EUR 13-3. Y+1: 5,539 EUR 13-4. Beyond Y+1: 2,770 EUR
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solian | Experimental | Drug: amisulprideAmisulpride (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 |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amisulprideAlso: SolianAmisulpride (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 | Solian |
Primary outcome
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
1 secondary outcome
gene
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- Background: PubMed 8949263Friston KJ. Theoretical neurobiology and schizophrenia. Br Med Bull. 1996 Jul;52(3):644-55. doi: 10.1093/oxfordjournals.bmb.a011573.
- Background: PubMed 7583624Friston KJ, Frith CD. Schizophrenia: a disconnection syndrome? Clin Neurosci. 1995;3(2):89-97.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-Hyuk Lee, MD., PhD. principal investigator
Associate Professor at Bundang CHA hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amisulpride in people with Schizophrenia and Schizophreniform Disorder, run by CHA University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain structural MRI (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02095938, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.