Sulforaphane to Reduce Symptoms of Schizophrenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT02810964

Run by

Sheppard Pratt Health System

People needed

64

Starts

2017-02-22

Expected to finish

2019-11-11

Last updated by the study team

2021-07-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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