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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Sulforaphane Nutraceutical 6 tablets by mouth daily
Identical-appearing Placebo 6 tablets by mouth daily
Sheppart Pratt Health System
Towson, Maryland, United States
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase
The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.
Time frame: 16 weeks (week 2 to week 18)
Change in MATRICS Consensus Cognitive Battery (MCCB) Overall Composite Scores From the Start to the End of the Study
The MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery (MCCB) is a standardized battery of 10 tests that measure 7 domains of cognitive performance: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. Overall composite t-scores are calculated using scores from all subtests. A t-score of 50 (10) is the mean (standard deviation) of the relevant reference population. Higher values indicate better performance.
Time frame: 18 weeks (week 0 to week 18)
Change in C-Reactive Protein From the Start to the End of the Study
Time frame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in Pentraxin-3 From the Start to the End of the Study
Time frame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in Anti-Saccharomyces Cerevisiae IgA Class Antibodies From the Start to the End of the Study
Time frame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
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Change in Interleukin-6 From the Start to the End of the Study
Time frame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in Tumor Necrosis Factor - Alpha From the Start to the End of the Study
Time frame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Change in Interferon Gamma From the Start to the End of the Study
Time frame: 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)