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

NCT04521868 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: Jiangyin-Sulforaphane
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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. The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.

Conditions

Schizophrenia

Keywords

schizophrenia; sulforaphane

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• side effects by TESS

  24 weeks

• Change of clinical symptoms by SANS

  24 weeks

• Change of clinical symptoms of CGI

  24 weeks

• Change of psychological, social, and occupational functioning by GAF

  24 weeks

Study Arms (2)

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.

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.

Dietary Supplement: placebo

Interventions

Sulforaphane DRUG

Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.

Also known as: Nutramax

sulforaphane

placebo DIETARY_SUPPLEMENT

Placebo is made of starch

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Second Xiangya Hospital

Changsha, Hunan, 410008, China

Location

Related Publications (1)

• 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.

  PMID: 39832347 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Renrong Wu, M.D Ph.D

  Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and researchers are blind to treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: August 31, 2020
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

CN (1)