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Completed

NCT Number: NCT02810964

Sulforaphane to Reduce 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sheppart Pratt Health System

Towson, Maryland, 21204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulforaphane Nutraceutical

Drug

Sulforaphane Nutraceutical 6 tablets by mouth daily

Other names: Avmacol®

Identical-appearing Placebo

Drug

Identical-appearing Placebo 6 tablets by mouth daily

Primary outcomes

  1. Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase

    Time frame: 16 weeks (week 2 to week 18)

    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.

Secondary outcomes

  1. Change in MATRICS Consensus Cognitive Battery (MCCB) Overall Composite Scores From the Start to the End of the Study

    Time frame: 18 weeks (week 0 to week 18)

    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.

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

Sponsors and collaborators

Lead sponsor

Sheppard Pratt Health System

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 23, 2016
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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