Sulforaphane to Reduce Symptoms of Schizophrenia

NCT02810964 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: SMRI/SPHS: 2016-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Schizoaffective Disorder; Sulforaphane; Sulforaphane supplement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

• 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)

Study Arms (2)

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.

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.

Drug: Identical-appearing Placebo

Interventions

Sulforaphane Nutraceutical DRUG

Sulforaphane Nutraceutical 6 tablets by mouth daily

Also known as: Avmacol®

Sulforaphane Nutraceutical

Identical-appearing Placebo DRUG

Identical-appearing Placebo 6 tablets by mouth daily

Identical-appearing Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheppard Pratt Health System: lead

Study Sites (1)

Sheppart Pratt Health System

Towson, Maryland, 21204, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Faith Dickerson
• Organization: Sheppard Pratt

fdickerson@sheppardpratt.org

410-938-4359

Study Officials

• Faith Dickerson, PhD, MPH

  Sheppard Pratt Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Stanley Research Program

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 23, 2016
• Study Start: February 22, 2017
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: July 27, 2021
• Results First Posted: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)