Sulforaphane to Reduce Symptoms of Schizophrenia

• Status: Completed
• Trial end date: 2019-11-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheppard Pratt Health System
• Treatments: Sulforafan; Sulforaphane

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