Sulforaphane to Reduce Symptoms of Schizophrenia

NCT ID: NCT02810964

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2019-11-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sulforaphane Nutraceutical

Intervention Type: DRUG

Sulforaphane Nutraceutical 6 tablets by mouth daily

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.

Group Type: PLACEBO_COMPARATOR

Identical-appearing Placebo

Intervention Type: DRUG

Identical-appearing Placebo 6 tablets by mouth daily

Interventions

Sulforaphane Nutraceutical

Sulforaphane Nutraceutical 6 tablets by mouth daily

Intervention Type: DRUG

Identical-appearing Placebo

Identical-appearing Placebo 6 tablets by mouth daily

Intervention Type: DRUG

Other Intervention Names

Avmacol®

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheppard Pratt Health System

OTHER

Sponsor Role: lead

Responsible Party

Faith Dickerson

Principal Investigator, Stanley Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faith Dickerson, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Sheppard Pratt Health System

Locations

Sheppart Pratt Health System

Towson, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SMRI/SPHS: 2016-01

Identifier Type: -

Identifier Source: org_study_id