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| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
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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.
This study will be carried out in six mental health institutes in China and total of 180 patients with first-episode or early onset schizophrenia will be enrolled into the study. The mental health institute at the Second Xiangya Hospital, Central South University.
Individuals who participate in the study will be followed for 24 weeks. The changes in clinical symptoms and neurocognitive function will be assessed from baseline (week-2) to week-6 (acute phase), and week-12 to week-24 (maintenance phase).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dose sulforaphane | Active Comparator | The goal of the study is to investigate whether adding high doses of sulforaphane will benefit the clinical symptoms and cognitive function in individuals who have schizophrenia. |
|
| low dose sulforaphane | Active Comparator | The goal of the study is to investigate whether adding low doses of sulforaphane will benefit the clinical symptoms and cognitive function in individuals who have schizophrenia. |
|
| placebo | Placebo Comparator | The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sulforaphane | Dietary Supplement | Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| side effects by SAFTEE | The investigators will evaluate side effect by The Systematic Assessment for Treatment Emergent Events (SAFTEE). | 24 weeks |
| side effects by AIMS | The investigators will evaluate side effect by Abnormal Involuntary Movement Scale (AIMS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianjun Ou, M.D Ph.D | Central South University | Principal Investigator |
| Renrong Wu, M.D Ph.D | Central South University | Principal Investigator |
| Jingping Zhao, M.D Ph.D | Central South University | Study Chair |
| Hua Jin, M.D Ph.D | University of California, San Diego | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15207938 | Background | 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. doi: 10.1016/S0165-0327(03)00135-6. | |
| 20974172 | Background | 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. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C016766 | sulforaphane |
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Participants and researchers are blind to treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.
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| placebo | Other | Placebo is made of starch |
|
| 24 weeks |
| side effects by BAS | The investigators will evaluate side effect by Barnes Akathisia Rating Scale (BAS). | 24 weeks |
| side effects by SAS | The investigators will evaluate side effect bySimpson-Angus Scale (SAS). | 24 weeks |
| 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 |
| Change of clinical symptoms of CGI | The change of Clinical Global Impression (CGI) before and after treatment at different follow up point | 24 weeks |