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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024641
Receipt No. R000028347
Scientific Title An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients with Schizophrenia
Date of disclosure of the study information 2016/10/31
Last modified on 2016/10/31

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Basic information
Public title An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients with
Schizophrenia
Acronym Open study of Sulforaphane for schizophrenia
Scientific Title An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients with
Schizophrenia
Scientific Title:Acronym Open study of Sulforaphane for schizophrenia
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of sulforaphane in medicated patients with schizophrenia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of the total score of PANSS between before and after taking sulforaphane
Key secondary outcomes The change of each score of CogState test battery between before and after taking sulforaphane.
The data of blood exams.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Participants take 3 tablets of Sulforaphane (SFN), consisting of 30 mg of SFN-glucosinolate per day, for 8 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Meeting criteria defined by the Diagnostic and Statistical Manual of Mental Disorders 4th ddition test revised.
Outpatients from Chiba University Hospital.
Being prescribed a single atypical antipsychotic drug (aripiprazole, blonanserin, olanzapine, paliperidone, perospirone, quetiapine, or risperidone) at a fixed dose, for at least 4 weeks before study entry.
Key exclusion criteria Not knowing the clnical diagnoses.
Diagnosed with intellectual disabilities, developmental disorders, attention-deficit hyperactivity disorders, delirium, dementia or other types of cognitive impairmentimpairment, substance misuse disorders (except caffeine or nicotine), eating disorders, or personality disorders.
Necessary to take strict diet, or other serious medical conditions.
With a history of taking clozapine.
With a history of taking antipsychotic depot injection, electro-convulsive therapy, or transcutaneous magnetic stimulation therapy within 3 months.
Previously being administered SFN over 8 weeks.
With allergic reaction to some kind of vegetable.
Having extraordinary eating behaviors.
Pregnant women and new mothers.
Having a history of participating other clinical trials within 3 months.
Unstable physical or psychological status.
Having a history of suicide attempt within 1 year.
Any other conditions so that the doctor in charge deny the indication.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaomi Iyo
Organization Chiba University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address Inohana, 1-8-1, Chuoh-ku, Chiba-shi, Chiba
TEL 043-222-7171
Email iyom@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Shiina
Organization Chiba University Center for Forensic Mental Health
Division name Division of Medical Treatment and Rehabilitation
Zip code
Address Inohana, 1-8-1, Chuoh-ku, Chiba-shi, Chiba
TEL 043-222-7171
Homepage URL
Email shiina-akihiro@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT01716858
Org. issuing International ID_1 the U.S. National Institutes of Health
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4423155/
Number of participants that the trial has enrolled
Results
A total of 7 patients completed the trial. The mean score in the Accuracy component of the One Card Learning Task increased significantly after the trial. However, we detected no other significant changes in participants.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 26 Day
Last follow-up date
2013 Year 06 Month 14 Day
Date of closure to data entry
2013 Year 06 Month 14 Day
Date trial data considered complete
2013 Year 06 Month 14 Day
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 31 Day
Last modified on
2016 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028347

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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