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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2016 by Central South University
Sponsor:
Information provided by (Responsible Party):
Renrong Wu, Central South University
ClinicalTrials.gov Identifier:
NCT02880462
First received: August 15, 2016
Last updated: August 25, 2016
Last verified: August 2016
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Dietary Supplement: sulforaphane
Other: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Effect of add-on Sulforaphane in Treatment of Schizophrenia

Resource links provided by NLM:


Further study details as provided by Central South University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • side effects by SAFTEE [ Time Frame: 24 weeks ]
    The investigators will evaluate side effect by The Systematic Assessment for Treatment Emergent Events (SAFTEE).

  • side effects by AIMS [ Time Frame: 24 weeks ]
    The investigators will evaluate side effect by Abnormal Involuntary Movement Scale (AIMS)

  • side effects by BAS [ Time Frame: 24 weeks ]
    The investigators will evaluate side effect by Barnes Akathisia Rating Scale (BAS).

  • side effects by SAS [ Time Frame: 24 weeks ]
    The investigators will evaluate side effect bySimpson-Angus Scale (SAS).

  • 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

  • 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


Estimated Enrollment: 180
Study Start Date: September 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Dietary Supplement: sulforaphane
Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.
Other Name: Nutramax
Active Comparator: 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.
Dietary Supplement: sulforaphane
Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.
Other Name: Nutramax
Placebo Comparator: placebo
The purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.
Other: placebo
Placebo is made of starch

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).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02880462

Contacts
Contact: Renrong Wu, M.D Ph.D wurenrong2013@163.com
Contact: Jingping Zhao, M.D Ph.D zhaojingpingcsu@163.com

Sponsors and Collaborators
Central South University
Investigators
Principal Investigator: Jianjun Ou, M.D Ph.D Central South University
Principal Investigator: Ranran Li, M.D Ph.D Central South University
Principal Investigator: Renrong Wu, M.D Ph.D Central South University
Study Chair: Jingping Zhao, M.D Ph.D Central South University
  More Information

Publications:
Responsible Party: Renrong Wu, Professor, Central South University
ClinicalTrials.gov Identifier: NCT02880462     History of Changes
Other Study ID Numbers: Stanley-Sulforaphane
Study First Received: August 15, 2016
Last Updated: August 25, 2016
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by Central South University:
schizophrenia
sulforaphane

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 24, 2017