Sulforaphane to Reduce Symptoms of Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Drug: Sulforaphane Nutraceutical; Drug: Identical-appearing Placebo

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Towson, Maryland, United States, 21204
      • Sheppart Pratt Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Sulforaphane Nutraceutical; Sulforaphane Nutraceutical 6 tablets by mouth daily; Other Names: Avmacol®
Placebo Comparator: 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.	Drug: Identical-appearing Placebo; Identical-appearing Placebo 6 tablets by mouth daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 weeks (week 2 to week 18)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 weeks (week 0 to week 18)
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 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)
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 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 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)

Collaborators and Investigators

• Sponsor: Sheppard Pratt Health System
• Investigators: Principal Investigator: Faith Dickerson, PhD, MPH, Sheppard Pratt Health System

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2017
• Primary Completion (Actual): November 11, 2019
• Study Completion (Actual): November 11, 2019

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimate): June 23, 2016

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Schizophrenia; Schizoaffective Disorder; Sulforaphane; Sulforaphane supplement
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Antineoplastic Agents; Protective Agents; Anticarcinogenic Agents; Sulforaphane
• Other Study ID Numbers: SMRI/SPHS: 2016-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No