Schizophrenia DisorderNCT07652866
Mechanisms of Sulforaphane Supplementation in Alleviating Negative Symptoms and Cognitive Impairment in Schizophrenia
A study testing Sulforaphane in people with Schizophrenia Disorder, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Schizophrenia Disorder
- What is being tested?
- Sulforaphane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xiangya Second Hospital
Changsha, China, 410001
Jing Huang, +8613107212438, jinghuangserena@csu.edu.cn
About this study
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.
- Conditions
- Schizophrenia Disorder
- Being tested
- Placebo, Sulforaphane
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
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.
SulforaphaneDietary supplement
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).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| sulforaphane | Experimental | Not described Receives: Dietary Supplement: Sulforaphane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Positive and Negative Syndrome Scale (PANSS) negative subscale score
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.
Measured: Baseline to 6 and 12 weeks
Change from baseline in Brief Negative Symptom Scale (BNSS) score
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.
Measured: Baseline to 6 and 12 weeks
Secondary outcomes (19)
Change from baseline in MATRICS Consensus Cognitive Battery (MCCB) score
The MCCB assesses seven cognitive domains. Positive change indicates cognitive improvement.
Measured: Baseline to 12 weeks
Brain imaging changes
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.
Measured: Baseline to 12 weeks
Change in serum biomarker levels
Evaluation of peripheral blood biomarkers of inflammation, oxidative stress and metabolism
Measured: Baseline to 12 weeks
Change in PANSS negative subscale score (open-label extension)
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.
Measured: Week 12 to 24
Change in Brief Negative Symptom Scale (BNSS) (open-label extension)
BNSS total score (0-78, higher=worse). Change = 24-week score minus week-12 score. Negative change indicates further improvement during extension.
Measured: Week 12 to 24
Change in the composite score of MATRICS Consensus Cognitive Battery (MCCB) (open-label extension)
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
Measured: Week 12 to 24
Change in serum biomarker levels (open-label extension)
Serum biomarker concentrations. Change = level at 24 weeks minus level at week 12.
Measured: Week 12 to 24
Clinical Global Impression - Severity of Illness (CGI-SI) score
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.
Measured: Baseline to 6 and 12 weeks
Clinical Global Impression - Global Improvement (CGI-GI) score
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.
Measured: Week 6 and week 12
Change in Self-rating Negative Symptom Scale (SNS) score
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.
Measured: Baseline to 6 and 12 weeks
Change in Personal and Social Performance (PSP) total score
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.
Measured: Baseline to 6 and 12 weeks
Change in Barnes Akathisia Rating Scale (BARS) total score
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.
Measured: Baseline to 6 and 12 weeks
Change in Systematic Assessment for Treatment Emergent Events (SAFTEE) total score
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.
Measured: Baseline to 6 and 12 weeks
Clinical Global Impression - Severity of Illness (CGI-SI) score (open-label extension)
CGI-SI rates illness severity on a 7-point scale (1=normal, 7=extremely ill).
Measured: Week 24
Clinical Global Impression - Global Improvement (CGI-GI) score (open-label extension)
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.
Measured: Week 24
Change in Self-rating Negative Symptom Scale (SNS) score (open-label extension)
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.
Measured: Week 12 to 24
Change in Personal and Social Performance (PSP) total score (open-label extension)
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.
Measured: Week 12 to 24
Change in BARS total score (open-label extension)
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.
Measured: Week 12 to 24
Change in Systematic Assessment for Treatment Emergent Events (SAFTEE) total score (open-label extension)
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.
Measured: Week 12 to 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start2 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisorderStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An interventional, randomized controlled clinical trial with an open-label extension study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Huang, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652866
- Sponsor's protocol ID
- LYG20210114
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Sulforaphane Supplementation in Alleviating Negative Symptoms and Cognitive Impairment in Schizophrenia
- ClinicalTrials.gov ID
- NCT07652866
- Acronym / sponsor ID
- LYG20210114
- Conditions
- Schizophrenia Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 2 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- An interventional, randomized controlled clinical trial with an open-label extension study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| sulforaphane | Experimental | Dietary Supplement: Sulforaphane |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboParticipants 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. | Dietary supplement | Placebo |
| SulforaphaneParticipants 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). | Dietary supplement | sulforaphane |
Primary outcome
Change from baseline in the Positive and Negative Syndrome Scale (PANSS) negative subscale score
Time frame: 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.
Change from baseline in Brief Negative Symptom Scale (BNSS) score
Time frame: 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.
19 secondary outcomes
Change from baseline in MATRICS Consensus Cognitive Battery (MCCB) score
Time frame: Baseline to 12 weeks
Brain imaging changes
Time frame: Baseline to 12 weeks
Change in serum biomarker levels
Time frame: Baseline to 12 weeks
Change in PANSS negative subscale score (open-label extension)
Time frame: Week 12 to 24
Change in Brief Negative Symptom Scale (BNSS) (open-label extension)
Time frame: Week 12 to 24
Change in the composite score of MATRICS Consensus Cognitive Battery (MCCB) (open-label extension)
Time frame: Week 12 to 24
Change in serum biomarker levels (open-label extension)
Time frame: Week 12 to 24
Clinical Global Impression - Severity of Illness (CGI-SI) score
Time frame: Baseline to 6 and 12 weeks
Clinical Global Impression - Global Improvement (CGI-GI) score
Time frame: Week 6 and week 12
Change in Self-rating Negative Symptom Scale (SNS) score
Time frame: Baseline to 6 and 12 weeks
Change in Personal and Social Performance (PSP) total score
Time frame: Baseline to 6 and 12 weeks
Change in Barnes Akathisia Rating Scale (BARS) total score
Time frame: Baseline to 6 and 12 weeks
Change in Systematic Assessment for Treatment Emergent Events (SAFTEE) total score
Time frame: Baseline to 6 and 12 weeks
Clinical Global Impression - Severity of Illness (CGI-SI) score (open-label extension)
Time frame: Week 24
Clinical Global Impression - Global Improvement (CGI-GI) score (open-label extension)
Time frame: Week 24
Change in Self-rating Negative Symptom Scale (SNS) score (open-label extension)
Time frame: Week 12 to 24
Change in Personal and Social Performance (PSP) total score (open-label extension)
Time frame: Week 12 to 24
Change in BARS total score (open-label extension)
Time frame: Week 12 to 24
Change in Systematic Assessment for Treatment Emergent Events (SAFTEE) total score (open-label extension)
Time frame: Week 12 to 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulforaphane in people with Schizophrenia Disorder, run by Second Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Huang, Prof. (+8613107212438, jinghuangserena@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Positive and Negative Syndrome Scale (PANSS) negative subscale score (time frame: Baseline to 6 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.