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Sulforaphane to Reduce Symptoms of Schizophrenia

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ClinicalTrials.gov Identifier: NCT02810964
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Faith Dickerson, Sheppard Pratt Health System

Tracking Information
First Submitted Date  ICMJE June 14, 2016
First Posted Date  ICMJE June 23, 2016
Last Update Posted Date January 6, 2020
Actual Study Start Date  ICMJE February 22, 2017
Actual Primary Completion Date November 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2016)
  • Change in MATRICS Consensus Cognitive Battery (MCCB) Scores [ Time Frame: 18 weeks (week 0 to week 18) ]
  • Measurement of Biomarkers [ Time Frame: 18 weeks (week 0, week 10, & week 18) ]
    Biomarkers measured in this trial include C-reactive protein and heat shock protein.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sulforaphane to Reduce Symptoms of Schizophrenia
Official Title  ICMJE A Double-Blind Placebo-Controlled Trial of a Sulforaphane Nutraceutical to Reduce the Symptoms of Schizophrenia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
Intervention  ICMJE
  • Drug: Sulforaphane Nutraceutical
    Sulforaphane Nutraceutical 6 tablets by mouth daily
    Other Name: Avmacol®
  • Drug: Identical-appearing Placebo
    Identical-appearing Placebo 6 tablets by mouth daily
Study Arms  ICMJE
  • Experimental: Sulforaphane Nutraceutical
    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.
    Intervention: Drug: Sulforaphane Nutraceutical
  • Placebo Comparator: Identical-appearing Placebo
    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.
    Intervention: Drug: Identical-appearing Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2016)
64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 11, 2019
Actual Primary Completion Date November 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02810964
Other Study ID Numbers  ICMJE SMRI/SPHS: 2016-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Responsible Party Faith Dickerson, Sheppard Pratt Health System
Study Sponsor  ICMJE Sheppard Pratt Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Faith Dickerson, PhD, MPH Sheppard Pratt Health System
PRS Account Sheppard Pratt Health System
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP