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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulforaphane Nutraceutical | Experimental | The sulforaphane nutraceutical contains inactive glucoraphanin, a glucosinolate from broccoli seeds, and myrosinase from broccoli sprouts. The ingestion of this compound leads to the hydrolysis of glucoraphanin, the generation of sulforaphane within the gastrointestinal (GI) tract, and the subsequent systemic absorption of the sulforaphane. The dose per tablet is 16 mg of glucoraphanin or 37 µmol; 6 tablets per day should yield about 100 µmol of sulforaphane. The tablets, which will be swallowed, are provided as .375 punch size, round concave tablets. In this arm, the participant will take 6 tablets of the sulforaphane nutraceutical daily for 16 weeks after a 2-week placebo run-in. |
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| Identical-appearing Placebo | Placebo Comparator | The inert compound placebo looks identical to the sulforaphane nutraceutical. In this arm, the participant will take 6 tablets of the placebo daily for 16 weeks after a 2-week placebo run-in. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulforaphane Nutraceutical | Drug | Sulforaphane Nutraceutical 6 tablets by mouth daily |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Faith Dickerson, PhD, MPH | Sheppard Pratt Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheppart Pratt Health System | Towson | Maryland | 21204 | United States |
Demographic, symptom, and cognitive data will be shared with the National Database for Clinical Trials Related to Mental Illness (NDCT). Access may be obtained through an approved application with the NDCT.
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We used a 2 week single-blind placebo phase for all participants prior to randomization. This placebo run-in was followed by the 16 week double-blind treatment phase.
We enrolled n=64 participants drawn from rehabilitation and treatment programs in Central Maryland. Dates of recruitment: February 2017 - June 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sulforaphane Nutraceutical | Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks |
| FG001 | Identical-appearing Placebo | Identical-appearing placebo 6 tablets by mouth daily for 16 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo Run-In Phase (2 Weeks) |
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| Double-Blind Treatment Phase (16 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sulforaphane Nutraceutical | Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks |
| BG001 | Identical-appearing Placebo | Identical-appearing placebo 6 tablets by mouth daily for 16 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 16 weeks (week 2 to week 18) |
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Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sulforaphane Nutraceutical | Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Schizophrenia exacerbation | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Faith Dickerson | Sheppard Pratt | 410-938-4359 | fdickerson@sheppardpratt.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2019 | Apr 14, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Identical-appearing Placebo | Drug | Identical-appearing Placebo 6 tablets by mouth daily |
|
| 18 weeks (week 0 to week 18) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Identical-appearing Placebo |
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks |
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| 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. | Posted | Mean | Standard Deviation | t scores | 18 weeks (week 0 to week 18) |
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| Secondary | Change in C-Reactive Protein From the Start to the End of the Study | Posted | Mean | Standard Deviation | ng/ml | 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported) |
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| Secondary | Change in Pentraxin-3 From the Start to the End of the Study | Posted | Mean | Standard Deviation | ng/ml | 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported) |
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| Secondary | Change in Anti-Saccharomyces Cerevisiae IgA Class Antibodies From the Start to the End of the Study | Posted | Mean | Standard Deviation | units/ml | 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported) |
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| Secondary | Change in Interleukin-6 From the Start to the End of the Study | Posted | Mean | Standard Deviation | pg/m | 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported) |
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| Secondary | Change in Tumor Necrosis Factor - Alpha From the Start to the End of the Study | Posted | Mean | Standard Deviation | pg/m | 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported) |
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| Secondary | Change in Interferon Gamma From the Start to the End of the Study | Posted | Mean | Standard Deviation | pg/m | 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported) |
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| 0 |
| 32 |
| 2 |
| 32 |
| 28 |
| 32 |
| EG001 | Identical-appearing Placebo | Identical-appearing placebo 6 tablets by mouth daily for 16 weeks | 0 | 32 | 5 | 32 | 20 | 32 |
| Cholecystitis | Gastrointestinal disorders | Systematic Assessment |
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| Knee replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Congestive heart failure | Cardiac disorders | Systematic Assessment |
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| Cardiovascular symptoms | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal symptoms | Gastrointestinal disorders | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Endocrine/metabolic symptoms | Endocrine disorders | Systematic Assessment |
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| Dermatological symptoms | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Urinary symptoms | Renal and urinary disorders | Systematic Assessment |
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| Psychiatric symptoms | Psychiatric disorders | Systematic Assessment |
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| Hematological symptoms | Blood and lymphatic system disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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