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

NCT07652866 | Not Yet Recruiting DMC

• 1 other identifier: LYG20210114
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to 6 and 12 weeks

Secondary Outcomes (19)

• Change from baseline in MATRICS Consensus Cognitive Battery (MCCB) score

  Baseline to 12 weeks

• Brain imaging changes

  Baseline to 12 weeks

• Change in serum biomarker levels

  Baseline to 12 weeks

• Change in PANSS negative subscale score (open-label extension)

  Week 12 to 24

• Change in Brief Negative Symptom Scale (BNSS) (open-label extension)

  Week 12 to 24

Other Outcomes (3)

• Complete Blood Count (CBC)

  Baseline, week 12 and week 24

• Blood Biochemistry

  Baseline, week 12 and week 24

• Biochemistry of renal function (creatinine, urea)

  Baseline, week 12 and week 24

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

sulforaphane

EXPERIMENTAL

Dietary Supplement: Sulforaphane

Interventions

Placebo DIETARY_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.

Placebo

Sulforaphane DIETARY_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).

sulforaphane

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Hepatic or renal impairment: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) \> 2× upper limit of normal (ULN); and/or creatinine \> 1.2× ULN or \> 2 mg/dL; or any other evidence of significant liver/kidney damage as judged by the investigator.
• Presence of hepatic or renal insufficiency, severe gastrointestinal, respiratory, endocrine, or hematologic disorders, or disorders of absorption or metabolism.
• Any laboratory value significantly outside the reference range and clinically significant as judged by the investigator.
• Pregnant or breastfeeding women.
• Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in this trial.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Second Hospital

Changsha, 410001, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Jing Huang, Prof.

CONTACT

+8613107212438; jinghuangserena@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: An interventional, randomized controlled clinical trial with an open-label extension study

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 17, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

CN (1)