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Mechanisms of Sulforaphane Supplementation in Alleviating Negative Symptoms and Cognitive Impairment in Schizophrenia

17 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  1. Diagnosis of schizophrenia according to DSM-5 criteria.
  2. First-episode or illness duration ≤ 10 years, but currently in a non-acute phase of schizophrenia.
  3. Negative symptoms present for ≥ 6 months prior to study entry. Patients must be outpatients or hospitalized for social reasons rather than symptom exacerbation.
  4. 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.
  5. Currently taking ≤ 2 antipsychotic medications.
  6. Antipsychotic regimen remains unchanged during the study period.
  7. No anticipated relocation, transportation difficulties, or access problems that would interfere with study participation.
  8. 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:

  1. Psychiatric symptoms attributable to any other DSM-5 diagnosis besides schizophrenia.
  2. History of substance dependence, or psychotic symptoms caused by other medical conditions.
  3. Calgary Depression Scale for Schizophrenia (CDSS) total score > 6.
  4. Barnes Akathisia Rating Scale (BARS) score indicating at least moderate akathisia.
  5. Current or past major physical illness, neurological disorder, or traumatic brain injury affecting brain structure/function.
  6. Suicidal attempt or current suicidal ideation.
  7. Currently receiving antidepressants, mood stabilizers; or use of rTMS, MECT, or systematic psychotherapy within 3 months or for the current episode.
  8. Current use of medications that may affect cognitive function, such as Ginkgo biloba extract, minocycline, selegiline.
  9. Presence of hepatic or renal insufficiency, severe gastrointestinal, respiratory, endocrine, or hematologic disorders, or disorders of absorption or metabolism.
  10. Pregnant or breastfeeding women.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
Suplement diety: Placebo
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.
Eksperymentalny: sulforaphane
Suplement diety: Sulforaphane
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).

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline in the Positive and Negative Syndrome Scale (PANSS) negative subscale score
Ramy czasowe: Baseline to 6 and 12 weeks
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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from baseline in MATRICS Consensus Cognitive Battery (MCCB) score
Ramy czasowe: Baseline to 12 weeks
The MCCB assesses seven cognitive domains. Positive change indicates cognitive improvement.
Baseline to 12 weeks
Brain imaging changes
Ramy czasowe: 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.
Baseline to 12 weeks
Change in serum biomarker levels
Ramy czasowe: Baseline to 12 weeks
Evaluation of peripheral blood biomarkers of inflammation, oxidative stress and metabolism
Baseline to 12 weeks
Change in PANSS negative subscale score (open-label extension)
Ramy czasowe: Week 12 to 24
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)
Ramy czasowe: Week 12 to 24
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)
Ramy czasowe: Week 12 to 24
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)
Ramy czasowe: Week 12 to 24
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
Ramy czasowe: 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
Clinical Global Impression - Global Improvement (CGI-GI) score
Ramy czasowe: Week 6 and week 12
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
Ramy czasowe: Baseline to 6 and 12 weeks
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
Ramy czasowe: Baseline to 6 and 12 weeks
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
Ramy czasowe: 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.
Baseline to 6 and 12 weeks
Change in Systematic Assessment for Treatment Emergent Events (SAFTEE) total score
Ramy czasowe: Baseline to 6 and 12 weeks
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)
Ramy czasowe: Week 24
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)
Ramy czasowe: 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.
Week 24
Change in Self-rating Negative Symptom Scale (SNS) score (open-label extension)
Ramy czasowe: Week 12 to 24
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)
Ramy czasowe: 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.
Week 12 to 24
Change in BARS total score (open-label extension)
Ramy czasowe: 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.
Week 12 to 24
Change in Systematic Assessment for Treatment Emergent Events (SAFTEE) total score (open-label extension)
Ramy czasowe: 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.
Week 12 to 24

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Complete Blood Count (CBC)
Ramy czasowe: Baseline, week 12 and week 24
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
Ramy czasowe: Baseline, week 12 and week 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)
Ramy czasowe: Baseline, week 12 and week 24
Evaluation of renal function (creatinine, urea), as well as change from baseline at week 12 and week 24.
Baseline, week 12 and week 24

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Second Xiangya Hospital of Central South University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

2 czerwca 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2028

Ukończenie studiów (Szacowany)

31 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

9 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

17 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • LYG20210114

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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