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Sulforaphane to Reduce Symptoms of Schizophrenia

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ClinicalTrials.gov Identifier: NCT02810964
Recruitment Status : Enrolling by invitation
First Posted : June 23, 2016
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Faith Dickerson, PhD, MPH, Sheppard Pratt Health System

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Sulforaphane Nutraceutical Drug: Identical-appearing Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Trial of a Sulforaphane Nutraceutical to Reduce the Symptoms of Schizophrenia
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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.
Drug: Sulforaphane Nutraceutical
Sulforaphane Nutraceutical 6 tablets by mouth daily
Other Name: Avmacol®

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.
Drug: Identical-appearing Placebo
Identical-appearing Placebo 6 tablets by mouth daily




Primary Outcome Measures :
  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 Outcome Measures :
  1. Change in MATRICS Consensus Cognitive Battery (MCCB) Scores [ Time Frame: 18 weeks (week 0 to week 18) ]
  2. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810964


Locations
United States, Maryland
Sheppart Pratt Health System
Towson, Maryland, United States, 21204
Sponsors and Collaborators
Sheppard Pratt Health System
Investigators
Principal Investigator: Faith Dickerson, PhD, MPH Sheppard Pratt Health System

Responsible Party: Faith Dickerson, PhD, MPH, Principal Investigator, Stanley Research Program, Sheppard Pratt Health System
ClinicalTrials.gov Identifier: NCT02810964     History of Changes
Other Study ID Numbers: SMRI/SPHS: 2016-01
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
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.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Faith Dickerson, PhD, MPH, Sheppard Pratt Health System:
Schizophrenia
Schizoaffective Disorder
Sulforaphane
Sulforaphane supplement

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents