Mechanisms of Sulforaphane Supplementation in Alleviating Negative Symptoms and Cognitive Impairment in Schizophrenia
2026年6月17日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jing Huang, Prof.
- 電話番号：+8613107212438
- メール：jinghuangserena@csu.edu.cn
研究場所
-
-
China
-
Changsha、China、中国、410001
- Xiangya Second Hospital
-
コンタクト：
- Jing Huang
- 電話番号：+8613107212438
- メール：jinghuangserena@csu.edu.cn
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
いいえ
説明
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.
- Presence of hepatic or renal insufficiency, severe gastrointestinal, respiratory, endocrine, or hematologic disorders, or disorders of absorption or metabolism.
- Pregnant or breastfeeding women.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：プラセボ
|
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.
|
|
実験的：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).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in the Positive and Negative Syndrome Scale (PANSS) negative subscale score
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in MATRICS Consensus Cognitive Battery (MCCB) score
時間枠：Baseline to 12 weeks
|
The MCCB assesses seven cognitive domains.
Positive change indicates cognitive improvement.
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Baseline to 12 weeks
|
|
Brain imaging changes
時間枠：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
|
|
Change in serum biomarker levels
時間枠：Baseline to 12 weeks
|
Evaluation of peripheral blood biomarkers of inflammation, oxidative stress and metabolism
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Baseline to 12 weeks
|
|
Change in PANSS negative subscale score (open-label extension)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Complete Blood Count (CBC)
時間枠：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
時間枠：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)
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月2日
一次修了 (推定)
2028年12月31日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年6月9日
QC基準を満たした最初の提出物
2026年6月16日
最初の投稿 (実際)
2026年6月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月18日
QC基準を満たした最後の更新が送信されました
2026年6月17日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- LYG20210114
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。