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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880462
• Other study ID #: Stanley-Sulforaphane
• Status: Completed
• Phase: Phase 2
• Start date: December 26, 2016
• Est. completion date: May 20, 2019

Study information

• Verified date: March 2020
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: May 20, 2019
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Dietary Supplement:
• sulforaphane
Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.

Other:
• placebo
Placebo is made of starch

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Central South University	Stanley Medical Research Institute

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

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