UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024641 |
|---|---|
| Receipt number | 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 10:39:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
shiina-akihiro@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
