A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Schizophrenia

Phase 2 Study of the Effect of add-on Sulforaphane in Treatment of Schizophrenia

The goal of the study is to investigate whether adding different doses of sulforaphane will benefit the clinical 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: Dietary supplement: sulforaphane; Other: placebo

Detailed Description

This study will be carried out in six mental health institutes in China and total of 180 patients with first-episode or early onset schizophrenia will be enrolled into the study. The mental health institute at the Second Xiangya Hospital, Central South University.

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-2) to week-6 (acute phase), and week-12 to week-24 (maintenance phase).

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Meet The Diagnostic and Statistical Manual (DSM-V) diagnostic criteria for schizophrenia
2. First onset or duration of illness less than 3 years with current symptoms exacerbation
3. Hospitalized in an acute episode (first hospitalization), or subsequent hospitalization or acute relapse)
4. Male and female with aged 18 to 50 years
5. PANSS total >=75 at 2 weeks. .
6. Signed the study consent for participation

Exclusion Criteria:

1. having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders;
2. having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system;
3. taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment;
4. having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting;
5. the routine blood tests showing abnormal renal, liver function or other metabolic results .
6. 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

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects by SAFTEE	The investigators will evaluate side effect by The Systematic Assessment for Treatment Emergent Events (SAFTEE).	24 weeks
side effects by AIMS	The investigators will evaluate side effect by Abnormal Involuntary Movement Scale (AIMS)	24 weeks
side effects by BAS	The investigators will evaluate side effect by Barnes Akathisia Rating Scale (BAS).	24 weeks
side effects by SAS	The investigators will evaluate side effect bySimpson-Angus Scale (SAS).	24 weeks
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	24 weeks
Change of clinical symptoms of CGI	The change of Clinical Global Impression (CGI) before and after treatment at different follow up point	24 weeks

Collaborators and Investigators

• Sponsor: Central South University
• Collaborators: Stanley Medical Research Institute
• Investigators: Principal Investigator: Jianjun Ou, M.D Ph.D, Central South University; Principal Investigator: Renrong Wu, M.D Ph.D, Central South University; Study Chair: Jingping Zhao, M.D Ph.D, Central South University; Principal Investigator: Hua Jin, M.D Ph.D, University of California, San Diego

Publications and helpful links

General Publications

• Selley ML. Increased (E)-4-hydroxy-2-nonenal and asymmetric dimethylarginine concentrations and decreased nitric oxide concentrations in the plasma of patients with major depression. J Affect Disord. 2004 Jun;80(2-3):249-56. doi: 10.1016/S0165-0327(03)00135-6.
• Bitanihirwe BK, Woo TU. Oxidative stress in schizophrenia: an integrated approach. Neurosci Biobehav Rev. 2011 Jan;35(3):878-93. doi: 10.1016/j.neubiorev.2010.10.008. Epub 2010 Oct 23.

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2016
• Primary Completion (Actual): May 20, 2019
• Study Completion (Actual): May 20, 2019

Study Registration Dates

• First Submitted: August 15, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 26, 2016

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 22, 2020
• Last Verified: March 1, 2020

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: Stanley-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: No
• Studies a U.S. FDA-regulated device product: No