Sulforaphane to Reduce Symptoms of Schizophrenia

• ClinicalTrials.gov Identifier: NCT02810964
• Recruitment Status: Completed
• First Posted: June 23, 2016
• Results First Posted: July 27, 2021
• Last Update Posted: July 27, 2021
• Sponsor: Sheppard Pratt Health System
• Information provided by (Responsible Party): Faith Dickerson, Sheppard Pratt Health System

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Schizoaffective Disorder	Drug: Sulforaphane Nutraceutical; Drug: Identical-appearing Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-Blind Placebo-Controlled Trial of a Sulforaphane Nutraceutical to Reduce the Symptoms of Schizophrenia
• Actual Study Start Date: February 22, 2017
• Actual Primary Completion Date: November 11, 2019
• Actual Study Completion Date: November 11, 2019

Arms and Interventions

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 Name: 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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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) ]
   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.
2. 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) ]
3. 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) ]
4. 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) ]
5. 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) ]
6. 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) ]
7. 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) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Maryland

Sheppart Pratt Health System

Towson, Maryland, United States, 21204

Sponsors and Collaborators

Sheppard Pratt Health System

Investigators

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

  Study Documents (Full-Text)

Documents provided by Faith Dickerson, Sheppard Pratt Health System:

Study Protocol and Statistical Analysis Plan  [PDF] April 17, 2019

More Information

• Responsible Party: Faith Dickerson, Principal Investigator, Stanley Research Program, Sheppard Pratt Health System
• ClinicalTrials.gov Identifier: NCT02810964
• Other Study ID Numbers: SMRI/SPHS: 2016-01
• First Posted: June 23, 2016
• Results First Posted: July 27, 2021
• Last Update Posted: July 27, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Faith Dickerson, Sheppard Pratt Health System:

Schizophrenia; Schizoaffective Disorder; Sulforaphane; Sulforaphane supplement

Additional relevant MeSH terms:

Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Sulforaphane; Anticarcinogenic Agents; Protective Agents; Physiological Effects of Drugs; Antineoplastic Agents