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

2026년 6월 17일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

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연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인

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아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약
건강 보조 식품: 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.
실험적: sulforaphane
건강 보조 식품: 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).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from baseline in the Positive and Negative Syndrome Scale (PANSS) negative subscale score
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change from baseline in MATRICS Consensus Cognitive Battery (MCCB) score
기간: Baseline to 12 weeks
The MCCB assesses seven cognitive domains. Positive change indicates cognitive improvement.
Baseline to 12 weeks
Brain imaging changes
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Complete Blood Count (CBC)
기간: 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
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Second Xiangya Hospital of Central South University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 2일

기본 완료 (추정된)

2028년 12월 31일

연구 완료 (추정된)

2028년 12월 31일

연구 등록 날짜

최초 제출

2026년 6월 9일

QC 기준을 충족하는 최초 제출

2026년 6월 16일

처음 게시됨 (실제)

2026년 6월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 17일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • LYG20210114

개별 참가자 데이터(IPD) 계획

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미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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