SchizophreniaPhase 2NCT01716858
An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients With Schizophrenia
A Phase 2 study testing Sulforaphane-rich Broccoli Sprout Extract in people with Schizophrenia, run by Chiba University at 1 site in Japan.
Trial summary
Accumulating evidence suggests a role of oxidative stress in the pathophysiology of schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels sprouts and cabbage. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Sulforaphane-rich Broccoli Sprout Extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2012to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Schizophrenia for DSM-IV TR criteria
- Patients are treated with an antipsychotic drug (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone).
- Patients are stable for 4-weeks for antipsychotic medication.
Who cannot join
- Patients treated with clozapine
- Patients treated with two or more antipsychotic drugs
- Pregnant or breast-feeding women
- Patients treated with sulforaphane for more than 8-weeks in the past.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sulforaphane-rich Broccoli Sprout Extract for Schizophrenia
Accumulating evidence suggests a role of oxidative stress in the pathophysiology of schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels sprouts and cabbage. The protection afforded by SFN is thought to be mediated via activation of the NF-E2-related factor-2 (Nrf2) pathway and subsequent up-regulation of phase II detoxification enzymes and antioxidant proteins, through an enhancer sequence referred to as the electrophilic responsive element or antioxidant responsive element. Recently, we reported that SFN could attenuate behavioral abnormalities in mice after the NMDA receptor antagonist phencyclidine. Considering the potent antioxidant effects of SFN, we have a hypothesis that SFN would be a potential therapeutic drug for schizophrenia. The purpose of this study is to determine whether SFN-rich broccoli sprout extract have beneficial effects in patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Sulforaphane-rich Broccoli Sprout Extract
- Keywords
- Schizophrenia, Sulforaphane, Psychosis, Cognition, Oxidative stress, Antioxidant, Anti-inflammatory
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulforaphane-rich Broccoli Sprout ExtractDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| A single-arm study | Experimental | Not described Receives: Dietary Supplement: Sulforaphane-rich Broccoli Sprout Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS)
Measured: Change from baseline in PANSS scores at 8-weeks
Secondary outcomes (1)
Cognition using CogState Research Battery
Measured: Change from baseline in the scores of the battery at 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiba University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenji Hashimoto, Chiba University
- Investigators
- Masaomi Iyo, MD, PhD, Study chair, Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716858
- Sponsor's protocol ID
- Chiba_SFN_Openstudy2012
- Status last verified
- Oct 2012
- First submitted
- 22 Oct 2012
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shiina A, Kanahara N, Sasaki T, Oda Y, Hashimoto T, Hasegawa T, Yoshida T, Iyo M, Hashimoto K. An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients with Schizophrenia. Clin Psychopharmacol Neurosci. 2015 Apr 30;13(1):62-7. doi: 10.9758/cpn.2015.13.1.62.
PubMed 25912539
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sulforaphane-rich Broccoli Sprout Extract for Schizophrenia
- ClinicalTrials.gov ID
- NCT01716858
- Acronym / sponsor ID
- Chiba_SFN_Openstudy2012
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Sulforaphane, Psychosis, Cognition, Oxidative stress, Antioxidant, Anti-inflammatory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chiba UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Accumulating evidence suggests a role of oxidative stress in the pathophysiology of schizophrenia. The potent antioxidant sulforaphane (SFN) is an organosulfur compound derived from a glucosinolate precursor found in cruciferous vegetables such as broccoli, Brussels sprouts and cabbage. The protection afforded by SFN is thought to be mediated via activation of the NF-E2-related factor-2 (Nrf2) pathway and subsequent up-regulation of phase II detoxification enzymes and antioxidant proteins, through an enhancer sequence referred to as the electrophilic responsive element or antioxidant responsive element. Recently, we reported that SFN could attenuate behavioral abnormalities in mice after the NMDA receptor antagonist phencyclidine. Considering the potent antioxidant effects of SFN, we have a hypothesis that SFN would be a potential therapeutic drug for schizophrenia. The purpose of this study is to determine whether SFN-rich broccoli sprout extract have beneficial effects in patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A single-arm study | Experimental | Dietary Supplement: Sulforaphane-rich Broccoli Sprout Extract |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Schizophrenia for DSM-IV TR criteria
- Patients are treated with an antipsychotic drug (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone).
- Patients are stable for 4-weeks for antipsychotic medication.
Key exclusion criteria (4 listed)
- Patients treated with clozapine
- Patients treated with two or more antipsychotic drugs
- Pregnant or breast-feeding women
- Patients treated with sulforaphane for more than 8-weeks in the past.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulforaphane-rich Broccoli Sprout Extract | Dietary supplement | A single-arm study |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: Change from baseline in PANSS scores at 8-weeks
1 secondary outcome
Cognition using CogState Research Battery
Time frame: Change from baseline in the scores of the battery at 8-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Results publication: PubMed 25912539Shiina A, Kanahara N, Sasaki T, Oda Y, Hashimoto T, Hasegawa T, Yoshida T, Iyo M, Hashimoto K. An Open Study of Sulforaphane-rich Broccoli Sprout Extract in Patients with Schizophrenia. Clin Psychopharmacol Neurosci. 2015 Apr 30;13(1):62-7. doi: 10.9758/cpn.2015.13.1.62.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masaomi Iyo, MD, PhD study chair
Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulforaphane-rich Broccoli Sprout Extract in people with Schizophrenia, run by Chiba University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (PANSS) (time frame: Change from baseline in PANSS scores at 8-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01716858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.