SchizophreniaPhase 2NCT04521868
A 6-month Study to Evaluate Sulforaphane Effects in Schizophrenia Patients
A Phase 2 study testing Sulforaphane in people with Schizophrenia, run by Central South University at 1 site in China.
Trial summary
The goal of the study is to investigate whether adding sulforaphane will benefit the negative symptoms and cognitive function in individuals who have schizophrenia. This study will compare the sulforaphane with placebo. There is a thirty percent change (less than half) of receiving the placebo. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Sulforaphane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2020to 12 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet The Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia;
- First onset or duration of illness less than 30 years with current symptoms in a stable condition;
- Male and female aged 18 to 50 years;
- Total score greater than or equal to 20 on the sum of the seven items constituting the Positive and Negative Syndrome Scale (PANSS) negative symptoms; an item of PANSS negative symptoms >3 scores;
- Signed the study consent for participation.
Who cannot join
- has a history of substance dependence or abuse or whose symptoms are caused by other diagnosable mental disorders;
- has a history of traumatic brain injury, seizures, or other known neurological diseases of the central nervous system;
- taking antidepressants, stimulants, mood stabilizers, or received modified electroconvulsive therapy (MECT) or rTMS during the past three months;
- having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be managed during the trial;
- taking dementia-related drugs, minocycline, and other drugs that may affect cognitive function;
- Laboratory tests indicated significant abnormalities in blood routine, liver and kidney function, or other metabolic results;
- pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Negative Symptoms and Cognition Impairment of Schizophrenia Patients
The goal of the study is to investigate whether adding sulforaphane will benefit the negative symptoms and cognitive function in individuals who have schizophrenia.
This study will compare the sulforaphane with placebo. There is a thirty percent change (less than half) of receiving the placebo. The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.
Read the detailed description
This study will be carried out in The Third Jiangyin Hospital in China and total of 120 schizophrenia patients with one negative symptom item score of PANSS≥3 will be enrolled into the study. Individuals who participate in the study will be followed for 24 weeks. The changes in clinical symptoms and neurocognitive function will be assessed from baseline (week-0) to week-12, and week-24.
- Conditions
- Schizophrenia
- Being tested
- Sulforaphane, placebo
- Keywords
- schizophrenia, sulforaphane
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulforaphaneDrug
Also called Nutramax
Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.
placeboDietary supplement
Placebo is made of starch
| Study group | Role | What they receive |
|---|---|---|
| sulforaphane | Experimental | The goal of the study is to investigate whether adding sulforaphane will benefit the negative symptoms and cognitive function in individuals who have schizophrenia. Receives: Drug: Sulforaphane |
| placebo | Placebo comparator | The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of clinical symptoms by PANSS
The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point. The PANSS total score ranges from 30-210 points,the higher the score, the worse the symptoms.
Measured: 24 weeks
Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score
The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure.The MCCB total score is about 50 in healthy participants, patients with schizophrenia are reported to have scores as low as two standard deviations below the mean points; the higher the score, the better the cognition performance.
Measured: 24 weeks
Secondary outcomes (4)
side effects by TESS
The investigators will evaluate side effect by Treatment Emergent Symptom Scale. It is consisted of behavioural toxicity, laboratory abnormalities, nervous system, automatic nervous system, cardiovascular system and six other aspects, was used to evaluate adverse drug reactions based on the scores, ranging from 0 to 4 (the higher the score, the more serious the adverse reactions).
Measured: 24 weeks
Change of clinical symptoms by SANS
The change of Scale for Assessment of Negative Symptoms (SANS) to evaluate negative symptoms before and after treatment at different time point. It measures 25 items of negative symptoms across 5 categories: affective blunting, alogia, avolition-apathy, anhedonia-asociality, and inattention, ranging from 0-120.
Measured: 24 weeks
Change of clinical symptoms of CGI
The change of Clinical Global Impression (CGI) before and after treatment at different follow up point. Its assess Severity of Illness (CGI-S), Global Improvement (CGI-I), and Efficacy Index (CGI-E). CGI-S is a 7-point scale, the higher score means the more severe the illness; CGI-I is a 7 point scale, the higher score means the less improved symptoms after treatment; CGI-E is is a 4×4 rating scale that assesses the therapeutic effect of treatment with psychiatric medication and associated side effects.
Measured: 24 weeks
Change of psychological, social, and occupational functioning by GAF
The change of Global Assessment of Functioning (GAF) Scale before and after treatment at different follow up point.ranging from 0 to 100.The higher scores means the better functioning performance.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start31 Aug 2020
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renrong Wu, Central South University
- Investigators
- Renrong Wu, M.D Ph.D, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521868
- Sponsor's protocol ID
- Jiangyin-Sulforaphane
- Status last verified
- Apr 2023
- First submitted
- 18 Aug 2020
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huang J, Chen A, Jin H, Liu F, Hei G, Teng Z, Xiao J, Wu R, Zhao J, Davis JM, Shao P, Smith RC. Efficacy and Safety of Sulforaphane Added to Antipsychotics for the Treatment of Negative Symptoms of Schizophrenia: A Randomized Controlled Trial. J Clin Psychiatry. 2025 Jan 20;86(1):24m15272. doi: 10.4088/JCP.24m15272.
PubMed 39832347
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Negative Symptoms and Cognition Impairment of Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT04521868
- Acronym / sponsor ID
- Jiangyin-Sulforaphane
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, sulforaphane
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 21 Aug 2020 (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 the study is to investigate whether adding sulforaphane will benefit the negative symptoms and cognitive function in individuals who have schizophrenia.
This study will compare the sulforaphane with placebo. There is a thirty percent change (less than half) of receiving the placebo. The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.
Detailed description
This study will be carried out in The Third Jiangyin Hospital in China and total of 120 schizophrenia patients with one negative symptom item score of PANSS≥3 will be enrolled into the study. Individuals who participate in the study will be followed for 24 weeks. The changes in clinical symptoms and neurocognitive function will be assessed from baseline (week-0) to week-12, and week-24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sulforaphane | Experimental | Drug: SulforaphaneThe goal of the study is to investigate whether adding sulforaphane will benefit the negative symptoms and cognitive function in individuals who have schizophrenia. |
| placebo | Placebo comparator | Dietary Supplement: placeboThe purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Meet The Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia;
- First onset or duration of illness less than 30 years with current symptoms in a stable condition;
- Male and female aged 18 to 50 years;
- Total score greater than or equal to 20 on the sum of the seven items constituting the Positive and Negative Syndrome Scale (PANSS) negative symptoms; an item of PANSS negative symptoms >3 scores;
- Signed the study consent for participation.
Key exclusion criteria (7 listed)
- has a history of substance dependence or abuse or whose symptoms are caused by other diagnosable mental disorders;
- has a history of traumatic brain injury, seizures, or other known neurological diseases of the central nervous system;
- taking antidepressants, stimulants, mood stabilizers, or received modified electroconvulsive therapy (MECT) or rTMS during the past three months;
- having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be managed during the trial;
- taking dementia-related drugs, minocycline, and other drugs that may affect cognitive 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 |
|---|---|---|
| SulforaphaneAlso: NutramaxSulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants. | Drug | sulforaphane |
| placeboPlacebo is made of starch | Dietary supplement | placebo |
Primary outcome
Change of clinical symptoms by PANSS
Time frame: 24 weeks
The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point. The PANSS total score ranges from 30-210 points,the higher the score, the worse the symptoms.
Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score
Time frame: 24 weeks
The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure.The MCCB total score is about 50 in healthy participants, patients with schizophrenia are reported to have scores as low as two standard deviations below the mean points; the higher the score, the better the cognition performance.
4 secondary outcomes
side effects by TESS
Time frame: 24 weeks
Change of clinical symptoms by SANS
Time frame: 24 weeks
Change of clinical symptoms of CGI
Time frame: 24 weeks
Change of psychological, social, and occupational functioning by GAF
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Derived from this study: PubMed 39832347Huang J, Chen A, Jin H, Liu F, Hei G, Teng Z, Xiao J, Wu R, Zhao J, Davis JM, Shao P, Smith RC. Efficacy and Safety of Sulforaphane Added to Antipsychotics for the Treatment of Negative Symptoms of Schizophrenia: A Randomized Controlled Trial. J Clin Psychiatry. 2025 Jan 20;86(1):24m15272. doi: 10.4088/JCP.24m15272.
- 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. This study is not recruiting at the moment.
Renrong Wu, M.D Ph.D principal investigator
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulforaphane in people with Schizophrenia, run by 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 26 Apr 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of clinical symptoms by PANSS (time frame: 24 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?
On the ClinicalTrials.gov record for NCT04521868, which also lists 1 linked publication.
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 26 Apr 2023.