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The goal of this randomized, double-blind, placebo-controlled clinical trial with an open-label extension is to evaluate whether sulforaphane can improve negative symptoms and cognitive impairment, and to explore its underlying mechanisms in patients with schizophrenia (aged 12-45 years, both sexes, stable on antipsychotic medication). The study duration includes 12 weeks of double-blind treatment followed by a 12-week open-label extension. In the randomized controlled double-blind phase, a total of 60 participants will be randomized 1:1 to receive either six oral tablets (411 μmol GR) of sulforaphane (SFN group, n = 30) or placebo (placebo group, n = 30) for 12 weeks. In the open-label phase, participants will choose whether to continue taking the drugs originally assigned. The primary outcome is the change in PANSS and BNSS scores during the randomized double-blind phase. Secondary outcomes include changes in brain MRI measures, as well as changes in MCCB, CGI-SI, CGI-GI, PSP, SNS, and SAFTEE scores during the randomized double-blind phase; and changes in PANSS, BNSS, and MCCB scores during the open-label phase.SAFTEE scale, serious adverse event record and blood test will be used for safety monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
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| sulforaphane | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Participants take 6 tablets of matching placebo daily for the first 3 months (randomized double-blind phase). During the subsequent 3-month open-label extension phase, those who choose to continue their original assigned medication also take 6 tablets of matching placebo per day, i.e., six placebo tablets daily. Both active and placebo tablets are manufactured uniformly by Shenzhen Fushan Biotech Co., Ltd. (China), with identical appearance and similar smell and taste. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Positive and Negative Syndrome Scale (PANSS) negative subscale score | PANSS negative subscale assesses severity of negative symptoms (score range 7-49, higher = worse). Change scores are calculated as the score at each time point (6 and 12 weeks) minus the baseline score. A negative change at either time point indicates improvement. | Baseline to 6 and 12 weeks |
| Change from baseline in Brief Negative Symptom Scale (BNSS) score | The BNSS measures negative symptom severity (total score 0-78, higher = worse). Change from baseline = score at week minus baseline score (calculated separately for week 6 and week 12). A negative change at either time point indicates improvement. | Baseline to 6 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in MATRICS Consensus Cognitive Battery (MCCB) score | The MCCB assesses seven cognitive domains. Positive change indicates cognitive improvement. | Baseline to 12 weeks |
| Brain imaging changes |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Blood Count (CBC) | Evaluation of red blood cell count, white blood cell count, platelet count, hemoglobin, neutrophil percentage, lymphocyte percentage, and monocyte percentage, as well as change from baseline at week 12 and week 24. | Baseline, week 12 and week 24 |
| Blood Biochemistry |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Huang, Prof. | Contact | +8613107212438 | jinghuangserena@csu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Second Hospital | Changsha | China | 410001 | China |
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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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An interventional, randomized controlled clinical trial with an open-label extension study
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| Sulforaphane | Dietary Supplement | Participants take 6 tablets of sulforaphane daily for the first 3 months (randomized double-blind phase). During the subsequent 3-month open-label extension phase, those who choose to continue their original assigned medication also take 6 tablets of sulforaphane per day, equivalent to a dosage of six active tablets (411 μmol GR). The sulforaphane-producing dietary supplement, ZHIYINGUOSU, is provided at no cost by Shenzhen Fushan Biotech Co., Ltd. (China). |
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Evaluation of brain imaging changes from baseline at week 12. The scanning protocol includes structural imaging, functional imaging, diffusion imaging, myelin imaging, and magnetic resonance spectroscopy imaging, to systematically evaluate brain structure, functional connectivity, white matter microstructure, myelin integrity, and neurometabolic profiles in patients with schizophrenia.
| Baseline to 12 weeks |
| Change in serum biomarker levels | Evaluation of peripheral blood biomarkers of inflammation, oxidative stress and metabolism | Baseline to 12 weeks |
| Change in PANSS negative subscale score (open-label extension) | Evaluation of the change from week 12 in the negative symptom subscale of PANSS at week 24. Change = score at 24 weeks minus score at week 12. Negative change indicates further improvement during extension. | Week 12 to 24 |
| Change in Brief Negative Symptom Scale (BNSS) (open-label extension) | BNSS total score (0-78, higher=worse). Change = 24-week score minus week-12 score. Negative change indicates further improvement during extension. | Week 12 to 24 |
| Change in the composite score of MATRICS Consensus Cognitive Battery (MCCB) (open-label extension) | Evaluation of the score and change from week 12 in MCCB composite score at week 24. Change = 24-week score minus week-12 score. Positive change indicates further improvement during extension | Week 12 to 24 |
| Change in serum biomarker levels (open-label extension) | Serum biomarker concentrations. Change = level at 24 weeks minus level at week 12. | Week 12 to 24 |
| Clinical Global Impression - Severity of Illness (CGI-SI) score | CGI-SI rates illness severity on a 7-point scale (1=normal, 7=extremely ill). Change = score at week minus baseline score (separately for week 6 and week 12). Negative change indicates improvement. | Baseline to 6 and 12 weeks |
| Clinical Global Impression - Global Improvement (CGI-GI) score | The CGI-GI rates overall change on a 7-point scale (1=very much improved, 4=no change, 7=very much worse). The score at each time point (6 and 12 weeks) directly reflects improvement since baseline; lower scores mean greater improvement. | Week 6 and week 12 |
| Change in Self-rating Negative Symptom Scale (SNS) score | The SNS is a self-reported scale completed by the patient to assess the severity of negative symptoms. Each item is scored on a 3-point scale (0=strongly disagree, 1=slightly agree, 2=completely agree), yielding a total score ranging from 0 to 40, with higher scores indicating more severe negative symptoms. Change scores are calculated as the score at each time point (6 and 12 weeks) minus the baseline score. A negative change at either time point indicates symptomatic improvement. | Baseline to 6 and 12 weeks |
| Change in Personal and Social Performance (PSP) total score | The PSP total score ranges 1-100 (higher = better personal and social functioning). Change = week score minus baseline score (separately for week 6 and week 12). Positive change means functional improvement. | Baseline to 6 and 12 weeks |
| Change in Barnes Akathisia Rating Scale (BARS) total score | The BARS measures akathisia severity (total score 0-14, higher = worse). Change = week score minus baseline score (separately for week 6 and week 12). Negative change indicates reduced akathisia. | Baseline to 6 and 12 weeks |
| Change in Systematic Assessment for Treatment Emergent Events (SAFTEE) total score | The SAFTEE total score reflects adverse event burden (higher score = greater burden). Change = week score minus baseline score (separately for week 6 and week 12). Negative change means reduction in adverse events. | Baseline to 6 and 12 weeks |
| Clinical Global Impression - Severity of Illness (CGI-SI) score (open-label extension) | CGI-SI rates illness severity on a 7-point scale (1=normal, 7=extremely ill). | Week 24 |
| Clinical Global Impression - Global Improvement (CGI-GI) score (open-label extension) | The CGI-GI rates overall change on a 7-point scale (1=very much improved, 4=no change, 7=very much worse). The score at 24 weeks directly reflects improvement since baseline; lower scores mean greater improvement. | Week 24 |
| Change in Self-rating Negative Symptom Scale (SNS) score (open-label extension) | The SNS is a patient-reported outcome measuring negative symptom severity using a 3-point scale per item (0=strongly disagree, 1=slightly agree, 2=completely agree), with a total score range of 0 to 40 (higher = worse). Change is calculated as the score at 24 weeks minus the score at week 12. A negative change indicates further improvement in negative symptoms during the extension phase. | Week 12 to 24 |
| Change in Personal and Social Performance (PSP) total score (open-label extension) | The PSP total score ranges 1-100 (higher = better personal and social functioning). Change = week 24 score minus week 12 score. Positive change means functional improvement. | Week 12 to 24 |
| Change in BARS total score (open-label extension) | The BARS measures akathisia severity (total score 0-14, higher = worse). Change = week score minus baseline score (separately for week 6 and week 12). Negative change indicates reduced akathisia. | Week 12 to 24 |
| Change in Systematic Assessment for Treatment Emergent Events (SAFTEE) total score (open-label extension) | he SAFTEE total score reflects adverse event burden (higher score = greater burden). Change = week 24 score minus week 12 score. Negative change means reduction in adverse events. | Week 12 to 24 |
Evaluation of liver function (ALT, AST, ALP, total bilirubin, direct bilirubin, total protein, albumin), as well as change from baseline at week 12 and week 24. |
| Baseline, week 12 and week 24 |
| Biochemistry of renal function (creatinine, urea) | Evaluation of renal function (creatinine, urea), as well as change from baseline at week 12 and week 24. | Baseline, week 12 and week 24 |