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 |
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.
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
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