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Completed

NCT Number: NCT02880462

A 6-month Study to Evaluate Sulforaphane add-on Effects 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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Sulforaphane

Dietary Supplement

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

Other names: Nutramax

Placebo

Other

Placebo is made of starch

Primary outcomes

  1. Cognitive improvement assessed using the MATRICS Consensus Cognitive Battery (MCCB) composite score

    Time frame: 24 weeks

    The investigators will use the MATRICS Consensus Cognitive Battery (MCCB) Composite score as primary cognitive outcome measure.

Secondary outcomes

  1. side effects by SAFTEE

    Time frame: 24 weeks

    The investigators will evaluate side effect by The Systematic Assessment for Treatment Emergent Events (SAFTEE).

  2. side effects by AIMS

    Time frame: 24 weeks

    The investigators will evaluate side effect by Abnormal Involuntary Movement Scale (AIMS)

  3. side effects by BAS

    Time frame: 24 weeks

    The investigators will evaluate side effect by Barnes Akathisia Rating Scale (BAS).

  4. side effects by SAS

    Time frame: 24 weeks

    The investigators will evaluate side effect bySimpson-Angus Scale (SAS).

  5. Change of clinical symptoms by PANSS

    Time frame: 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

  6. Change of clinical symptoms of CGI

    Time frame: 24 weeks

    The change of Clinical Global Impression (CGI) before and after treatment at different follow up point

Sponsors and collaborators

Lead sponsor

Central South University

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 26, 2016
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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