UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients with Schizophrenia
Title of the study (Brief title)	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	Masaomi Iyo
Organization	Chiba University Graduate School of Medicine
Division name	Department of Psychiatry
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	Akihiro Shiina
Organization	Chiba University Center for Forensic Mental Health
Division name	Division of Medical Treatment and Rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4423155/
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.
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