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

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Dietary Supplement: sulforaphane; Other: placebo

• Registration Number: NCT02880462
• Lead Sponsor: Central South University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-26
• Study Start: 2016-12-26
• Primary Completion: 2019-05-20
• Study Completion: 2019-05-20
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-22
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high dose sulforaphane	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.
low dose sulforaphane	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.
placebo	placebo	The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.

Primary Outcome Measures

Name	Time	Method
Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score	24 weeks	The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure.

Secondary Outcome Measures

Name	Time	Method
side effects by BAS	24 weeks	The investigators will evaluate side effect by Barnes Akathisia Rating Scale (BAS).
Change of clinical symptoms by PANSS	24 weeks	The change of Positive And Negative Syndrome Scale (PANSS) total, positive and negative symptoms before and after treatment at different follow up point
Change of clinical symptoms of CGI	24 weeks	The change of Clinical Global Impression (CGI) before and after treatment at different follow up point
side effects by SAFTEE	24 weeks	The investigators will evaluate side effect by The Systematic Assessment for Treatment Emergent Events (SAFTEE).
side effects by AIMS	24 weeks	The investigators will evaluate side effect by Abnormal Involuntary Movement Scale (AIMS)
side effects by SAS	24 weeks	The investigators will evaluate side effect bySimpson-Angus Scale (SAS).