Mechanisms of Sulforaphane Supplementation in Alleviating Negative Symptoms and Cognitive Impairment in Schizophrenia
16. června 2026 aktualizováno: Jing Huang, Second Xiangya Hospital of Central South University
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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
60
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Jing Huang, Prof.
- Telefonní číslo: +8613107212438
- E-mail: jinghuangserena@csu.edu.cn
Studijní místa
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Changsha, Čína, 410001
- Xiangya Second Hospital
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Kontakt:
- Jing Huang
- Telefonní číslo: +8613107212438
- E-mail: jinghuangserena@csu.edu.cn
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Diagnosis of schizophrenia according to DSM-5 criteria.
- First-episode or illness duration ≤ 10 years, but currently in a non-acute phase of schizophrenia.
- Negative symptoms present for ≥ 6 months prior to study entry. Patients must be outpatients or hospitalized for social reasons rather than symptom exacerbation.
- PANSS negative subscale (7 items) total score ≥ 20; at least one negative item score > 3; no change > 3 points between screening and baseline. PANSS positive subscale items related to agitation (P4 excitement, P6 suspiciousness/persecution, P7 hostility, G8 uncooperativeness, G14 poor impulse control) each ≤ 4.
- Currently taking ≤ 2 antipsychotic medications.
- Antipsychotic regimen remains unchanged during the study period.
- No anticipated relocation, transportation difficulties, or access problems that would interfere with study participation.
- Able to understand and comply with study procedures, complete all required tests and examinations, communicate well with the investigator, and voluntarily provide written informed consent
Exclusion Criteria:
- Psychiatric symptoms attributable to any other DSM-5 diagnosis besides schizophrenia.
- History of substance dependence, or psychotic symptoms caused by other medical conditions.
- Calgary Depression Scale for Schizophrenia (CDSS) total score > 6.
- Barnes Akathisia Rating Scale (BARS) score indicating at least moderate akathisia.
- Current or past major physical illness, neurological disorder, or traumatic brain injury affecting brain structure/function.
- Suicidal attempt or current suicidal ideation.
- Currently receiving antidepressants, mood stabilizers; or use of rTMS, MECT, or systematic psychotherapy within 3 months or for the current episode.
- Current use of medications that may affect cognitive function, such as Ginkgo biloba extract, minocycline, selegiline.
- Hepatic or renal impairment: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) > 2× upper limit of normal (ULN); and/or creatinine > 1.2× ULN or > 2 mg/dL; or any other evidence of significant liver/kidney damage as judged by the investigator.
- Presence of hepatic or renal insufficiency, severe gastrointestinal, respiratory, endocrine, or hematologic disorders, or disorders of absorption or metabolism.
- Any laboratory value significantly outside the reference range and clinically significant as judged by the investigator.
- Pregnant or breastfeeding women.
- Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this trial.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Komparátor placeba: Placebo
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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.
|
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Experimentální: sulforaphane
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from baseline in the Positive and Negative Syndrome Scale (PANSS) negative subscale score
Časové okno: Baseline to 6 and 12 weeks
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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.
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Baseline to 6 and 12 weeks
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Change from baseline in Brief Negative Symptom Scale (BNSS) score
Časové okno: Baseline to 6 and 12 weeks
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from baseline in MATRICS Consensus Cognitive Battery (MCCB) score
Časové okno: Baseline to 12 weeks
|
The MCCB assesses seven cognitive domains.
Positive change indicates cognitive improvement.
|
Baseline to 12 weeks
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Brain imaging changes
Časové okno: Baseline to 12 weeks
|
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.
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Baseline to 12 weeks
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Change in serum biomarker levels
Časové okno: Baseline to 12 weeks
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Evaluation of peripheral blood biomarkers of inflammation, oxidative stress and metabolism
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Baseline to 12 weeks
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Change in PANSS negative subscale score (open-label extension)
Časové okno: Week 12 to 24
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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.
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Week 12 to 24
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Change in Brief Negative Symptom Scale (BNSS) (open-label extension)
Časové okno: Week 12 to 24
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BNSS total score (0-78, higher=worse).
Change = 24-week score minus week-12 score.
Negative change indicates further improvement during extension.
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Week 12 to 24
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Change in the composite score of MATRICS Consensus Cognitive Battery (MCCB) (open-label extension)
Časové okno: Week 12 to 24
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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
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Week 12 to 24
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Change in serum biomarker levels (open-label extension)
Časové okno: Week 12 to 24
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Serum biomarker concentrations.
Change = level at 24 weeks minus level at week 12.
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Week 12 to 24
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Clinical Global Impression - Severity of Illness (CGI-SI) score
Časové okno: Baseline to 6 and 12 weeks
|
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
|
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Clinical Global Impression - Global Improvement (CGI-GI) score
Časové okno: Week 6 and week 12
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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.
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Week 6 and week 12
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Change in Self-rating Negative Symptom Scale (SNS) score
Časové okno: Baseline to 6 and 12 weeks
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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.
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Baseline to 6 and 12 weeks
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Change in Personal and Social Performance (PSP) total score
Časové okno: Baseline to 6 and 12 weeks
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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.
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Baseline to 6 and 12 weeks
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Change in Barnes Akathisia Rating Scale (BARS) total score
Časové okno: Baseline to 6 and 12 weeks
|
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.
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Baseline to 6 and 12 weeks
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Change in Systematic Assessment for Treatment Emergent Events (SAFTEE) total score
Časové okno: Baseline to 6 and 12 weeks
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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.
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Baseline to 6 and 12 weeks
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Clinical Global Impression - Severity of Illness (CGI-SI) score (open-label extension)
Časové okno: Week 24
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CGI-SI rates illness severity on a 7-point scale (1=normal, 7=extremely ill).
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Week 24
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Clinical Global Impression - Global Improvement (CGI-GI) score (open-label extension)
Časové okno: Week 24
|
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.
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Week 24
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Change in Self-rating Negative Symptom Scale (SNS) score (open-label extension)
Časové okno: Week 12 to 24
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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.
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Week 12 to 24
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Change in Personal and Social Performance (PSP) total score (open-label extension)
Časové okno: Week 12 to 24
|
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.
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Week 12 to 24
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Change in BARS total score (open-label extension)
Časové okno: Week 12 to 24
|
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.
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Week 12 to 24
|
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Change in Systematic Assessment for Treatment Emergent Events (SAFTEE) total score (open-label extension)
Časové okno: Week 12 to 24
|
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.
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Week 12 to 24
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Complete Blood Count (CBC)
Časové okno: Baseline, week 12 and week 24
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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.
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Baseline, week 12 and week 24
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Blood Biochemistry
Časové okno: Baseline, week 12 and week 24
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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.
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Baseline, week 12 and week 24
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Biochemistry of renal function (creatinine, urea)
Časové okno: Baseline, week 12 and week 24
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Evaluation of renal function (creatinine, urea), as well as change from baseline at week 12 and week 24.
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Baseline, week 12 and week 24
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
2. června 2026
Primární dokončení (Odhadovaný)
31. prosince 2028
Dokončení studie (Odhadovaný)
31. prosince 2028
Termíny zápisu do studia
První předloženo
9. června 2026
První předloženo, které splnilo kritéria kontroly kvality
16. června 2026
První zveřejněno (Aktuální)
17. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
17. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
16. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
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