Schizophrenia Clinical Trial
Official title:
Phase 2 Study of the Effect of add-on Sulforaphane in Treatment of Schizophrenia
Verified date | March 2020 |
Source | Central South University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of the study is to investigate whether adding different doses of sulforaphane will
benefit the clinical symptoms and cognitive function in individuals who have schizophrenia.
This study will compare the sulforaphane with placebo. There is a thirty percent change (less
than half) of receiving the placebo. The purpose of including placebo is to judge if the
outcome is related to the study medication rather than other reasons.
Status | Completed |
Enrollment | 172 |
Est. completion date | May 20, 2019 |
Est. primary completion date | May 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. Meet The Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia 2. First onset or duration of illness less than 3 years with current symptoms exacerbation 3. Hospitalized in an acute episode (first hospitalization), or subsequent hospitalization or acute relapse) 4. Male and female with aged 18 to 50 years 5. PANSS total >=75 at 2 weeks. . 6. Signed the study consent for participation Exclusion Criteria: 1. having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders; 2. having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system; 3. taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment; 4. having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting; 5. the routine blood tests showing abnormal renal, liver function or other metabolic results . 6. pregnant or lactating women |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Central South University | Stanley Medical Research Institute |
Bitanihirwe BK, Woo TU. Oxidative stress in schizophrenia: an integrated approach. Neurosci Biobehav Rev. 2011 Jan;35(3):878-93. doi: 10.1016/j.neubiorev.2010.10.008. Epub 2010 Oct 23. Review. — View Citation
Selley ML. Increased (E)-4-hydroxy-2-nonenal and asymmetric dimethylarginine concentrations and decreased nitric oxide concentrations in the plasma of patients with major depression. J Affect Disord. 2004 Jun;80(2-3):249-56. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score | The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure. | 24 weeks | |
Secondary | side effects by SAFTEE | The investigators will evaluate side effect by The Systematic Assessment for Treatment Emergent Events (SAFTEE). | 24 weeks | |
Secondary | side effects by AIMS | The investigators will evaluate side effect by Abnormal Involuntary Movement Scale (AIMS) | 24 weeks | |
Secondary | side effects by BAS | The investigators will evaluate side effect by Barnes Akathisia Rating Scale (BAS). | 24 weeks | |
Secondary | side effects by SAS | The investigators will evaluate side effect bySimpson-Angus Scale (SAS). | 24 weeks | |
Secondary | Change of clinical symptoms by PANSS | The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point | 24 weeks | |
Secondary | Change of clinical symptoms of CGI | The change of Clinical Global Impression (CGI) before and after treatment at different follow up point | 24 weeks |
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