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

17 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • China
      • Changsha, China, China, 410001

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo
Suplemento dietético: 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.
Experimental: sulforaphane
Suplemento dietético: 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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in the Positive and Negative Syndrome Scale (PANSS) negative subscale score
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change from baseline in MATRICS Consensus Cognitive Battery (MCCB) score
Prazo: Baseline to 12 weeks
The MCCB assesses seven cognitive domains. Positive change indicates cognitive improvement.
Baseline to 12 weeks
Brain imaging changes
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Complete Blood Count (CBC)
Prazo: 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
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Second Xiangya Hospital of Central South University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

2 de junho de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2028

Conclusão do estudo (Estimado)

31 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

9 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de junho de 2026

Primeira postagem (Real)

17 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • LYG20210114

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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