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

NCT ID: NCT02880462

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-26
• Study Completion Date: 2019-05-20

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).

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

sulforaphane

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: ACTIVE_COMPARATOR

sulforaphane

Intervention Type: DIETARY_SUPPLEMENT

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

placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Placebo is made of starch

Interventions

sulforaphane

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

Intervention Type: DIETARY_SUPPLEMENT

placebo

Placebo is made of starch

Intervention Type: OTHER

Other Intervention Names

Nutramax

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanley Medical Research Institute

OTHER

Sponsor Role: collaborator

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Renrong Wu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianjun Ou, M.D Ph.D

Role: PRINCIPAL_INVESTIGATOR

Central South University

Renrong Wu, M.D Ph.D

Role: PRINCIPAL_INVESTIGATOR

Central South University

Jingping Zhao, M.D Ph.D

Role: STUDY_CHAIR

Central South University

Hua Jin, M.D Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

References

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.

Reference Type: BACKGROUND

PMID: 15207938 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20974172 (View on PubMed)

Other Identifiers

Stanley-Sulforaphane

Identifier Type: -

Identifier Source: org_study_id