Sulforaphane to Reduce Symptoms of Schizophrenia
|ClinicalTrials.gov Identifier: NCT02810964|
Recruitment Status : Enrolling by invitation
First Posted : June 23, 2016
Last Update Posted : May 30, 2018
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810964
|United States, Maryland|
|Sheppart Pratt Health System|
|Towson, Maryland, United States, 21204|
|Principal Investigator:||Faith Dickerson, PhD, MPH||Sheppard Pratt Health System|