Clinical trial NCT02810964: Sulforaphane to Reduce Symptoms of Schizophrenia
Official title: A Double-Blind Placebo-Controlled Trial of a Sulforaphane Nutraceutical to Reduce the Symptoms of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Schizoaffective Disorder
Sulforaphane
Sulforaphane supplement
Lead sponsor: Sheppard Pratt Health System
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase
timeFrame: 16 weeks (week 2 to week 18)
Secondary outcomes:
measure: Change in MATRICS Consensus Cognitive Battery (MCCB) Overall Composite Scores From the Start to the End of the Study
timeFrame: 18 weeks (week 0 to week 18)
measure: Change in C-Reactive Protein From the Start to the End of the Study
timeFrame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
measure: Change in Pentraxin-3 From the Start to the End of the Study
timeFrame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
measure: Change in Anti-Saccharomyces Cerevisiae IgA Class Antibodies From the Start to the End of the Study
timeFrame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
measure: Change in Interleukin-6 From the Start to the End of the Study
timeFrame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
measure: Change in Tumor Necrosis Factor - Alpha From the Start to the End of the Study
timeFrame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
measure: Change in Interferon Gamma From the Start to the End of the Study
timeFrame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Other outcomes:
Locations:
city: Towson
country: United States
facility: Sheppart Pratt Health System
state: Maryland
Study officials:
affiliation: Sheppard Pratt Health System
name: Faith Dickerson, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: