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

NCT02880462 | Completed Phase 2 DMC

• 1 other identifier: Stanley-Sulforaphane
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia

Keywords

schizophrenia; sulforaphane

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• side effects by SAFTEE

  24 weeks

• side effects by AIMS

  24 weeks

• side effects by BAS

  24 weeks

• side effects by SAS

  24 weeks

• Change of clinical symptoms by PANSS

  24 weeks

Study Arms (3)

high dose sulforaphane

ACTIVE COMPARATOR

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

low dose sulforaphane

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

sulforaphane DIETARY_SUPPLEMENT

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

Also known as: Nutramax

high dose sulforaphane; low dose sulforaphane

placebo OTHER

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

You may not qualify if:

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

Sponsors & Collaborators

• Central South University: lead
• Stanley Medical Research Institute: collaborator

Related Publications (2)

• 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.

  PMID: 15207938 BACKGROUND

• 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.

  PMID: 20974172 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Jianjun Ou, M.D Ph.D

  Central South University

  PRINCIPAL INVESTIGATOR

• Renrong Wu, M.D Ph.D

  Central South University

  PRINCIPAL INVESTIGATOR

• Jingping Zhao, M.D Ph.D

  Central South University

  STUDY CHAIR

• Hua Jin, M.D Ph.D

  University of California, San Diego

  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 15, 2016
• First Posted: August 26, 2016
• Study Start: December 26, 2016
• Primary Completion: May 20, 2019
• Study Completion: May 20, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03