Mechanisms of Sulforaphane Supplementation in Alleviating Negative Symptoms and Cognitive Impairment in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •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
排除标准
- •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 >
- •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.
研究组 & 干预措施
sulforaphane
干预措施: Sulforaphane (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
研究者
Jing Huang
Professor
Second Xiangya Hospital of Central South University