A 6-month Study to Evaluate Sulforaphane Effects in Schizophrenia Patients

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Sulforaphane; Dietary supplement: placebo

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 Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Second Xiangya Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 46 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Meet The Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia;
2. First onset or duration of illness less than 30 years with current symptoms in a stable condition;
3. Male and female aged 18 to 50 years;
4. 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;
5. Signed the study consent for participation.

Exclusion Criteria:

1. has a history of substance dependence or abuse or whose symptoms are caused by other diagnosable mental disorders;
2. has a history of traumatic brain injury, seizures, or other known neurological diseases of the central nervous system;
3. taking antidepressants, stimulants, mood stabilizers, or received modified electroconvulsive therapy (MECT) or rTMS during the past three months;
4. having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be managed during the trial;
5. taking dementia-related drugs, minocycline, and other drugs that may affect cognitive function;
6. Laboratory tests indicated significant abnormalities in blood routine, liver and kidney function, or other metabolic results;
7. pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.	Dietary supplement: placebo; Placebo is made of starch
Experimental: sulforaphane; The goal of the study is to investigate whether adding sulforaphane will benefit the negative symptoms and cognitive function in individuals who have schizophrenia.	Drug: Sulforaphane; Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.; Other Names: Nutramax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	24 weeks

Collaborators and Investigators

• Sponsor: Central South University
• Investigators: Principal Investigator: Renrong Wu, M.D Ph.D, Central South University

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Actual): August 12, 2022
• Study Completion (Actual): August 12, 2022

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: schizophrenia; sulforaphane
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Antineoplastic Agents; Protective Agents; Anticarcinogenic Agents; Sulforaphane
• Other Study ID Numbers: Jiangyin-Sulforaphane

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes