Sulforaphane to Reduce Symptoms of Schizophrenia



Status:Enrolling by invitation
Conditions:Schizophrenia, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:1/20/2019
Start Date:February 22, 2017
End Date:July 2019

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A Double-Blind Placebo-Controlled Trial of a Sulforaphane Nutraceutical to Reduce the Symptoms of Schizophrenia

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.


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
We found this trial at
1
site
6501 North Charles Street
Towson, Maryland 21204
?
mi
from
Towson, MD
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