Sulforaphane to Reduce Symptoms of Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02810964
• Other study ID #: SMRI/SPHS: 2016-01
• Status: Completed
• Phase: Phase 2
• Start date: February 22, 2017
• Est. completion date: November 11, 2019

Study information

• Verified date: July 2021
• Source: Sheppard Pratt Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 11, 2019
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Sulforaphane Nutraceutical
Sulforaphane Nutraceutical 6 tablets by mouth daily
• Identical-appearing Placebo
Identical-appearing Placebo 6 tablets by mouth daily

Locations

Country	Name	City	State
United States	Sheppart Pratt Health System	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sheppard Pratt Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 weeks (week 2 to week 18)
Secondary	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.	18 weeks (week 0 to week 18)
Secondary	Change in C-Reactive Protein From the Start to the End of the Study		18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Secondary	Change in Pentraxin-3 From the Start to the End of the Study		18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Secondary	Change in Anti-Saccharomyces Cerevisiae IgA Class Antibodies From the Start to the End of the Study		18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Secondary	Change in Interleukin-6 From the Start to the End of the Study		18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Secondary	Change in Tumor Necrosis Factor - Alpha From the Start to the End of the Study		18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Secondary	Change in Interferon Gamma From the Start to the End of the Study		18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)