Phase 2
N=64
Sulforaphane to Reduce Symptoms of Schizophrenia
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02810964 ↗Enrolled (actual)
64
Serious AEs
10.9%
Results posted
Jul 2021
Primary outcome: Primary: Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase — 81.0; 81.5; 81.7; 79.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sulforaphane Nutraceutical (Drug); Identical-appearing Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sheppard Pratt Health System
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase |
81.0; 81.5; 81.7; 79.7 | — |
| SECONDARY Change in MATRICS Consensus Cognitive Battery (MCCB) Overall Composite Scores From the Start to the End of the Study |
25.0; 19.5; 26.8; 22.8 | — |
| SECONDARY Change in C-Reactive Protein From the Start to the End of the Study |
10402.8; 8969.7; 10198.5; 10224.5 | — |
| SECONDARY Change in Pentraxin-3 From the Start to the End of the Study |
0.414; 0.461; 0.394; 0.558 | — |
| SECONDARY Change in Anti-Saccharomyces Cerevisiae IgA Class Antibodies From the Start to the End of the Study |
0.195; 0.168; 0.226; 0.176 | — |
| SECONDARY Change in Interleukin-6 From the Start to the End of the Study |
0.623; 0.704; 0.694; 0.673 | — |
| SECONDARY Change in Tumor Necrosis Factor - Alpha From the Start to the End of the Study |
0.668; 0.538; 0.638; 0.520 | — |
| SECONDARY Change in Interferon Gamma From the Start to the End of the Study |
0.514; 0.456; 0.478; 0.526 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
- Conformance to PORT Treatment Recommendation about Maintenance Antipsychotic Medication Dose
- Proficient in the English language
- Participated previously in one of our screening studies
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02810964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.