Sulforaphane to Reduce Symptoms of Schizophrenia

Phase 2

Completed

Conditions: Schizophrenia
Schizoaffective Disorder

Interventions: Drug: Sulforaphane Nutraceutical
Drug: Identical-appearing Placebo

Registration Number: NCT02810964

Lead Sponsor: Sheppard Pratt Health System

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 64

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sulforaphane Nutraceutical	Sulforaphane Nutraceutical	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.
Identical-appearing Placebo	Identical-appearing Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase	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.

Secondary Outcome Measures

Name	Time	Method
Change in Interferon Gamma From the Start to the End of the Study	18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in C-Reactive Protein From the Start to the End of the Study	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	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	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	18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in MATRICS Consensus Cognitive Battery (MCCB) Overall Composite Scores From the Start to the End of the Study	18 weeks (week 0 to week 18)	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.
Change in Pentraxin-3 From the Start to the End of the Study	18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)