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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2022-08-12

Brief Summary

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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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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Participants and researchers are blind to treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.

Study Groups

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sulforaphane

The goal of the study is to investigate whether adding sulforaphane will benefit the negative symptoms and cognitive function in individuals who have schizophrenia.

Group Type EXPERIMENTAL

Sulforaphane

Intervention Type DRUG

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 DIETARY_SUPPLEMENT

Placebo is made of starch

Interventions

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Sulforaphane

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

Intervention Type DRUG

placebo

Placebo is made of starch

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Nutramax

Eligibility Criteria

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Inclusion Criteria

1. Meet The Diagnostic and Statistical Manual (DSM-5) diagnostic criteria for schizophrenia;
2. First onset or duration of illness less than 30 years with current symptoms in a stable condition;
3. Male and female aged 18 to 50 years;
4. 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;
5. Signed the study consent for participation.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No