Mechanisms of Sulforaphane Supplementation in Alleviating Negative Symptoms and Cognitive Impairm… (NCT07652866) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mechanisms of Sulforaphane Supplementation in Alleviating Negative Symptoms and Cognitive Impairment in Schizophrenia
China60 participantsStarted 2026-06-02
Plain-language 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 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.
Who can participate
Age range
12 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a sulforaphane supplement — a compound found in broccoli sprouts — for schizophrenia's negative symptoms like low motivation and social withdrawal. Given my current symptom profile, does it make sense to discuss this as a possible option, or are my negative symptoms not the primary concern right now?
2The trial hasn't started recruiting yet — what does that mean for how soon I could realistically get involved, and is it worth waiting, or should we focus on optimizing my current treatment in the meantime?
3Since this is listed as Phase NA, what does that tell you about how much safety and effectiveness data already exists for sulforaphane in people with schizophrenia, and how would you weigh that uncertainty against my current needs?
4The trial is measuring changes on the PANSS and BNSS scales, which specifically track negative symptoms — things like flat affect, social withdrawal, and lack of motivation. How would we know whether I'm experiencing enough of those symptoms to make this trial particularly relevant to my situation?
5If sulforaphane is a natural compound, could I discuss it as a supplement on its own with my care team, or is participating in a structured trial like this the better way to explore it safely alongside my existing medications?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in the Positive and Negative Syndrome Scale (PANSS) negative subscale score
Timeframe: Baseline to 6 and 12 weeks
2
Change from baseline in Brief Negative Symptom Scale (BNSS) score
Timeframe: Baseline to 6 and 12 weeks
Trial details
NCT IDNCT07652866
SponsorSecond Xiangya Hospital of Central South University
. 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.