Sulforaphane to Reduce Symptoms of Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Sulforaphane Nutraceutical; Identical-appearing Placebo
Intervention description: Sulforaphane Nutraceutical 6 tablets by mouth daily; Identical-appearing Placebo 6 tablets by mouth daily
Intervention MeSH terms: Sulforaphane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Schizoaffective Disorder; Sulforaphane; Sulforaphane supplement

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.
    

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