SchizophreniaPhase 2NCT02810964
Sulforaphane to Reduce Symptoms of Schizophrenia
A Phase 2 study testing Sulforaphane Nutraceutical in people with Schizophrenia and Schizoaffective Disorder, run by Sheppard Pratt Health System at 1 site in United States.
Trial summary
The purpose of this study is to determine if taking a sulforaphane nutraceutical versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Sulforaphane Nutraceutical
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2017to 11 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capacity for written informed consent
- Age 18-65 years, inclusive
- Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as determined by the Structured Clinical Interview for DSM-5 Disorders (SCID-5)
- Currently an outpatient at time of screening
- Residual psychotic symptoms of at least moderate severity as evidenced by a Positive and Negative Syndrome Scale (PANSS) total score of 60 or higher AND one or more of the following: one or more PANSS positive symptom scores of 4 or higher; OR containing at least three positive or negative items with scores of 3 or higher at the screening visit
- Receiving antipsychotic medication for at least 8 weeks prior to enrolling in the study with no antipsychotic medication changes within the previous 21 days from visit 2 (week 0)
Show all 9Show fewer
- Conformance to PORT Treatment Recommendation about Maintenance Antipsychotic Medication Dose
- Proficient in the English language
- Participated previously in one of our screening studies
Who cannot join
- Any clinically significant or unstable medical disorder as determined by the principal investigator and/or the study physician (e.g., HIV infection or other immunodeficiency condition (such as receiving chemotherapy), uncontrolled diabetes, congestive heart failure)
- DSM-5 diagnosis of intellectual disability or comparable diagnoses determined by previous versions of the DSM
- DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within the last three months prior to the screening visit. If the patient has a positive drug toxicity screen at the time of visit 1 (screening), further evaluation by the investigator will be done of the substance use to determine eligibility.
- Any current use of a broccoli supplement (e.g., Avmacol® or other health food broccoli supplement)
- Participated in any investigational drug trial in the past 30 days prior to the screening visit
- Pregnant, planning to become pregnant, or breastfeeding during the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Sheppart Pratt Health System
Towson, Maryland, 21204
About this study
Official title: A Double-Blind Placebo-Controlled Trial of a Sulforaphane Nutraceutical to Reduce the Symptoms of Schizophrenia
The purpose of this study is to determine if taking a sulforaphane nutraceutical versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Sulforaphane Nutraceutical, Identical-appearing Placebo
- Keywords
- Schizophrenia, Schizoaffective Disorder, Sulforaphane, Sulforaphane supplement
- 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 NutraceuticalDrug
Also called Avmacol®
Sulforaphane Nutraceutical 6 tablets by mouth daily
Identical-appearing PlaceboDrug
Identical-appearing Placebo 6 tablets by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| Sulforaphane Nutraceutical | Experimental | The sulforaphane nutraceutical contains inactive glucoraphanin, a glucosinolate from broccoli seeds, and myrosinase from broccoli sprouts. The ingestion of this compound leads to the hydrolysis of glucoraphanin, the generation of sulforaphane within the gastrointestinal (GI) tract, and the subsequent systemic absorption of the sulforaphane. The dose per tablet is 16 mg of glucoraphanin or 37 µmol; 6 tablets per day should yield about 100 µmol of sulforaphane. The tablets, which will be swallowed, are provided as .375 punch size, round concave tablets. In this arm, the participant will take 6 tablets of the sulforaphane nutraceutical daily for 16 weeks after a 2-week placebo run-in. Receives: Drug: Sulforaphane Nutraceutical |
| Identical-appearing Placebo | Placebo comparator | The inert compound placebo looks identical to the sulforaphane nutraceutical. In this arm, the participant will take 6 tablets of the placebo daily for 16 weeks after a 2-week placebo run-in. Receives: Drug: Identical-appearing Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase
The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.
Measured: 16 weeks (week 2 to week 18)
Secondary outcomes (7)
Change in MATRICS Consensus Cognitive Battery (MCCB) Overall Composite Scores From the Start to the End of the Study
The MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery (MCCB) is a standardized battery of 10 tests that measure 7 domains of cognitive performance: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. Overall composite t-scores are calculated using scores from all subtests. A t-score of 50 (10) is the mean (standard deviation) of the relevant reference population. Higher values indicate better performance.
Measured: 18 weeks (week 0 to week 18)
Change in C-Reactive Protein From the Start to the End of the Study
Measured: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in Pentraxin-3 From the Start to the End of the Study
Measured: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in Anti-Saccharomyces Cerevisiae IgA Class Antibodies From the Start to the End of the Study
Measured: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in Interleukin-6 From the Start to the End of the Study
Measured: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in Tumor Necrosis Factor - Alpha From the Start to the End of the Study
Measured: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in Interferon Gamma From the Start to the End of the Study
Measured: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start22 Feb 2017
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheppard Pratt Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faith Dickerson, Sheppard Pratt Health System
- Investigators
- Faith Dickerson, PhD, MPH, Principal investigator, Sheppard Pratt Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810964
- Sponsor's protocol ID
- SMRI/SPHS: 2016-01
- Status last verified
- Jul 2021
- First submitted
- 14 Jun 2016
- Last updated
- 27 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic, symptom, and cognitive data will be shared with the National Database for Clinical Trials Related to Mental Illness (NDCT). Access may be obtained through an approved application with the NDCT.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo-Controlled Trial of a Sulforaphane Nutraceutical to Reduce the Symptoms of Schizophrenia
- ClinicalTrials.gov ID
- NCT02810964
- Acronym / sponsor ID
- SMRI/SPHS: 2016-01
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Schizoaffective Disorder, Sulforaphane, Sulforaphane supplement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sheppard Pratt Health SystemUniversity, hospital or other
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Posted 27 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if taking a sulforaphane nutraceutical versus a placebo will reduce symptoms of schizophrenia when used in addition to standard antipsychotic medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sulforaphane Nutraceutical | Experimental | Drug: Sulforaphane NutraceuticalThe sulforaphane nutraceutical contains inactive glucoraphanin, a glucosinolate from broccoli seeds, and myrosinase from broccoli sprouts. The ingestion of this compound leads to the hydrolysis of glucoraphanin, the generation of sulforaphane within the gastrointestinal (GI) tract, and the subsequent systemic absorption of the sulforaphane. The dose per tablet is 16 mg of glucoraphanin or 37 µmol; 6 tablets per day should yield about 100 µmol of sulforaphane. The tablets, which will be swallowed, are provided as .375 punch size, round concave tablets. In this arm, the participant will take 6 tablets of the sulforaphane nutraceutical daily for 16 weeks after a 2-week placebo run-in. |
| Identical-appearing Placebo | Placebo comparator | Drug: Identical-appearing PlaceboThe inert compound placebo looks identical to the sulforaphane nutraceutical. In this arm, the participant will take 6 tablets of the placebo daily for 16 weeks after a 2-week placebo run-in. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Capacity for written informed consent
- Age 18-65 years, inclusive
- Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as determined by the Structured Clinical Interview for DSM-5 Disorders (SCID-5)
- Currently an outpatient at time of screening
- Residual psychotic symptoms of at least moderate severity as evidenced by a Positive and Negative Syndrome Scale (PANSS) total score of 60 or higher AND one or more of the following: one or more PANSS positive symptom scores of 4 or higher; OR containing at least three positive or negative items with scores of 3 or higher at the screening visit
Key exclusion criteria (6 listed)
- Any clinically significant or unstable medical disorder as determined by the principal investigator and/or the study physician (e.g., HIV infection or other immunodeficiency condition (such as receiving chemotherapy), uncontrolled diabetes, congestive heart failure)
- DSM-5 diagnosis of intellectual disability or comparable diagnoses determined by previous versions of the DSM
- DSM-5 diagnosis of a moderate or severe substance use disorder, except for caffeine or tobacco, within the last three months prior to the screening visit. If the patient has a positive drug toxicity screen at the time of visit 1 (screening), further evaluation by the investigator will be done of the substance use to determine eligibility.
- Any current use of a broccoli supplement (e.g., Avmacol® or other health food broccoli supplement)
- Participated in any investigational drug trial in the past 30 days prior to the screening visit
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 NutraceuticalAlso: Avmacol®Sulforaphane Nutraceutical 6 tablets by mouth daily | Drug | Sulforaphane Nutraceutical |
| Identical-appearing PlaceboIdentical-appearing Placebo 6 tablets by mouth daily | Drug | Identical-appearing Placebo |
Primary outcome
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase
Time frame: 16 weeks (week 2 to week 18)
The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.
7 secondary outcomes
Change in MATRICS Consensus Cognitive Battery (MCCB) Overall Composite Scores From the Start to the End of the Study
Time frame: 18 weeks (week 0 to week 18)
Change in C-Reactive Protein From the Start to the End of the Study
Time frame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in Pentraxin-3 From the Start to the End of the Study
Time frame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in Anti-Saccharomyces Cerevisiae IgA Class Antibodies From the Start to the End of the Study
Time frame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in Interleukin-6 From the Start to the End of the Study
Time frame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in Tumor Necrosis Factor - Alpha From the Start to the End of the Study
Time frame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in Interferon Gamma From the Start to the End of the Study
Time frame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Demographic, symptom, and cognitive data will be shared with the National Database for Clinical Trials Related to Mental Illness (NDCT). Access may be obtained through an approved application with the NDCT.
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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.
Faith Dickerson, PhD, MPH principal investigator
Sheppard Pratt Health System
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 Nutraceutical in people with Schizophrenia and Schizoaffective Disorder, run by Sheppard Pratt Health System at 1 site in United States.
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 9 inclusion and 6 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 27 Jul 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 27 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase (time frame: 16 weeks (week 2 to week 18)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2021.