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NCT Number: NCT04521868

A 6-month Study to Evaluate Sulforaphane Effects in Schizophrenia Patients

The goal of the study is to investigate whether adding sulforaphane will benefit the negative 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

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Second Xiangya Hospital

Changsha, Hunan, 410008, China

About this study

This study will be carried out in The Third Jiangyin Hospital in China and total of 120 schizophrenia patients with one negative symptom item score of PANSS≥3 will be enrolled into the study. 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-0) to week-12, and week-24.

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-5) diagnostic criteria for schizophrenia;
  • First onset or duration of illness less than 30 years with current symptoms in a stable condition;
  • Male and female aged 18 to 50 years;
  • Total score greater than or equal to 20 on the sum of the seven items constituting the Positive and Negative Syndrome Scale (PANSS) negative symptoms; an item of PANSS negative symptoms >3 scores;
  • Signed the study consent for participation.

Exclusion criteria

  • has a history of substance dependence or abuse or whose symptoms are caused by other diagnosable mental disorders;
  • has a history of traumatic brain injury, seizures, or other known neurological diseases of the central nervous system;
  • taking antidepressants, stimulants, mood stabilizers, or received modified electroconvulsive therapy (MECT) or rTMS during the past three months;
  • having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be managed during the trial;
  • taking dementia-related drugs, minocycline, and other drugs that may affect cognitive function;
  • Laboratory tests indicated significant abnormalities in blood routine, liver and kidney function, or other metabolic results;
  • pregnant or lactating women.

Treatment and study plan

Sulforaphane

Drug

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

Other names: Nutramax

Placebo

Dietary Supplement

Placebo is made of starch

Primary outcomes

  1. 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. The PANSS total score ranges from 30-210 points,the higher the score, the worse the symptoms.

  2. 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.The MCCB total score is about 50 in healthy participants, patients with schizophrenia are reported to have scores as low as two standard deviations below the mean points; the higher the score, the better the cognition performance.

Secondary outcomes

  1. side effects by TESS

    Time frame: 24 weeks

    The investigators will evaluate side effect by Treatment Emergent Symptom Scale. It is consisted of behavioural toxicity, laboratory abnormalities, nervous system, automatic nervous system, cardiovascular system and six other aspects, was used to evaluate adverse drug reactions based on the scores, ranging from 0 to 4 (the higher the score, the more serious the adverse reactions).

  2. Change of clinical symptoms by SANS

    Time frame: 24 weeks

    The change of Scale for Assessment of Negative Symptoms (SANS) to evaluate negative symptoms before and after treatment at different time point. It measures 25 items of negative symptoms across 5 categories: affective blunting, alogia, avolition-apathy, anhedonia-asociality, and inattention, ranging from 0-120.

  3. 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. Its assess Severity of Illness (CGI-S), Global Improvement (CGI-I), and Efficacy Index (CGI-E). CGI-S is a 7-point scale, the higher score means the more severe the illness; CGI-I is a 7 point scale, the higher score means the less improved symptoms after treatment; CGI-E is is a 4×4 rating scale that assesses the therapeutic effect of treatment with psychiatric medication and associated side effects.

  4. Change of psychological, social, and occupational functioning by GAF

    Time frame: 24 weeks

    The change of Global Assessment of Functioning (GAF) Scale before and after treatment at different follow up point.ranging from 0 to 100.The higher scores means the better functioning performance.

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Official study title

A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Negative Symptoms and Cognition Impairment of Schizophrenia Patients

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 21, 2020
Registry last updated
Apr 26, 2023

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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