Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sulforaphane to Reduce Symptoms of Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02810964
Recruitment Status : Completed
First Posted : June 23, 2016
Results First Posted : July 27, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Faith Dickerson, Sheppard Pratt Health System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Schizophrenia
Schizoaffective Disorder
Interventions Drug: Sulforaphane Nutraceutical
Drug: Identical-appearing Placebo
Enrollment 64
Recruitment Details We enrolled n=64 participants drawn from rehabilitation and treatment programs in Central Maryland. Dates of recruitment: February 2017 - June 2019.
Pre-assignment Details 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.
Arm/Group Title Sulforaphane Nutraceutical Identical-appearing Placebo
Hide Arm/Group Description Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
Period Title: Placebo Run-In Phase (2 Weeks)
Started 32 32
Completed 32 32
Not Completed 0 0
Period Title: Double-Blind Treatment Phase (16 Weeks)
Started 32 32
Completed 29 29
Not Completed 3 3
Reason Not Completed
Withdrawal by Subject             1             2
Lost to Follow-up             1             0
Protocol Violation             0             1
Relocation             1             0
Arm/Group Title Sulforaphane Nutraceutical Identical-appearing Placebo Total
Hide Arm/Group Description Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks Identical-appearing placebo 6 tablets by mouth daily for 16 weeks Total of all reporting groups
Overall Number of Baseline Participants 32 32 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
32
 100.0%
32
 100.0%
64
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 32 participants 64 participants
42.7  (12.3) 45.8  (11.7) 44.2  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
Female
8
  25.0%
7
  21.9%
15
  23.4%
Male
24
  75.0%
25
  78.1%
49
  76.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
Caucasian 18 16 34
African American 14 16 30
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 32 participants 64 participants
32 32 64
1.Primary Outcome
Title Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase
Hide Description 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.
Time Frame 16 weeks (week 2 to week 18)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Nutraceutical Identical-appearing Placebo
Hide Arm/Group Description:
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
Wk 2 (Begin Treatment) PANSS Total Score 81.0  (12.2) 81.5  (13.0)
Wk 18 (End Treatment) PANSS Total Score 81.7  (13.3) 79.7  (14.6)
2.Secondary Outcome
Title Change in MATRICS Consensus Cognitive Battery (MCCB) Overall Composite Scores From the Start to the End of the Study
Hide Description 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.
Time Frame 18 weeks (week 0 to week 18)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Nutraceutical Identical-appearing Placebo
Hide Arm/Group Description:
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: t scores
Wk 0 (Baseline) MCCB Score 25.0  (12.0) 19.5  (13.4)
Wk 18 (End Treatment) MCCB Score 26.8  (12.6) 22.8  (13.6)
3.Secondary Outcome
Title Change in C-Reactive Protein From the Start to the End of the Study
Hide Description [Not Specified]
Time Frame 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Nutraceutical Identical-appearing Placebo
Hide Arm/Group Description:
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: ng/ml
CRP (Wk 0, Baseline) 10402.8  (13488.2) 8969.7  (9021.6)
CRP (Wk 18, End Treatment) 10198.5  (12110.9) 10224.5  (13654.0)
4.Secondary Outcome
Title Change in Pentraxin-3 From the Start to the End of the Study
Hide Description [Not Specified]
Time Frame 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Nutraceutical Identical-appearing Placebo
Hide Arm/Group Description:
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: ng/ml
Pentraxin(Wk 0, Baseline) 0.414  (0.534) 0.461  (0.603)
Pentraxin (Wk 18, End Treatment) 0.394  (0.569) 0.558  (0.695)
5.Secondary Outcome
Title Change in Anti-Saccharomyces Cerevisiae IgA Class Antibodies From the Start to the End of the Study
Hide Description [Not Specified]
Time Frame 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Nutraceutical Identical-appearing Placebo
Hide Arm/Group Description:
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: units/ml
ASCA IGA (Wk 0, Baseline) 0.195  (0.222) 0.168  (0.163)
ASCA IGA (Wk 18, End Treatment) 0.226  (0.277) 0.176  (0.184)
6.Secondary Outcome
Title Change in Interleukin-6 From the Start to the End of the Study
Hide Description [Not Specified]
Time Frame 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Nutraceutical Identical-appearing Placebo
Hide Arm/Group Description:
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: pg/m
IL-6 (Wk 0, Baseline) 0.623  (0.247) 0.704  (0.478)
IL-6 (Wk 18, End Treatment) 0.694  (0.288) 0.673  (0.357)
7.Secondary Outcome
Title Change in Tumor Necrosis Factor - Alpha From the Start to the End of the Study
Hide Description [Not Specified]
Time Frame 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Nutraceutical Identical-appearing Placebo
Hide Arm/Group Description:
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: pg/m
TNF-a (Wk 0, Baseline) 0.668  (0.393) 0.538  (0.211)
TNF-a (Wk 18, End Treatment) 0.638  (0.362) 0.520  (0.263)
8.Secondary Outcome
Title Change in Interferon Gamma From the Start to the End of the Study
Hide Description [Not Specified]
Time Frame 18 weeks (assessed at weeks 0, 10, and 18; weeks 0 and 18 reported)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sulforaphane Nutraceutical Identical-appearing Placebo
Hide Arm/Group Description:
Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks
Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
Overall Number of Participants Analyzed 29 29
Mean (Standard Deviation)
Unit of Measure: pg/m
IFN-g (Wk 0, Baseline) 0.514  (0.432) 0.456  (0.172)
IFN-g (Wk 18, End Treatment) 0.478  (0.335) 0.526  (0.222)
Time Frame Adverse events were collected over an 18 week period, including the 2 week placebo run-in and the 16 week double-blind treatment phase.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sulforaphane Nutraceutical Identical-appearing Placebo
Hide Arm/Group Description Sulforaphane nutraceutical 6 tablets by mouth daily for 16 weeks Identical-appearing placebo 6 tablets by mouth daily for 16 weeks
All-Cause Mortality
Sulforaphane Nutraceutical Identical-appearing Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)      0/32 (0.00%)    
Hide Serious Adverse Events
Sulforaphane Nutraceutical Identical-appearing Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/32 (6.25%)      5/32 (15.63%)    
Cardiac disorders     
Congestive heart failure   0/32 (0.00%)  0 1/32 (3.13%)  1
Gastrointestinal disorders     
Cholecystitis   0/32 (0.00%)  0 1/32 (3.13%)  1
Musculoskeletal and connective tissue disorders     
Knee replacement   0/32 (0.00%)  0 1/32 (3.13%)  1
Psychiatric disorders     
Schizophrenia exacerbation   2/32 (6.25%)  2 2/32 (6.25%)  3
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sulforaphane Nutraceutical Identical-appearing Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/32 (87.50%)      20/32 (62.50%)    
Blood and lymphatic system disorders     
Hematological symptoms   1/32 (3.13%)  1 0/32 (0.00%)  0
Cardiac disorders     
Cardiovascular symptoms   1/32 (3.13%)  1 3/32 (9.38%)  3
Endocrine disorders     
Endocrine/metabolic symptoms   4/32 (12.50%)  4 7/32 (21.88%)  8
Gastrointestinal disorders     
Gastrointestinal symptoms   12/32 (37.50%)  15 6/32 (18.75%)  8
General disorders     
Other   4/32 (12.50%)  4 5/32 (15.63%)  5
Musculoskeletal and connective tissue disorders     
Musculoskeletal pain   2/32 (6.25%)  2 3/32 (9.38%)  3
Psychiatric disorders     
Psychiatric symptoms   11/32 (34.38%)  14 5/32 (15.63%)  11
Renal and urinary disorders     
Urinary symptoms   2/32 (6.25%)  2 3/32 (9.38%)  3
Respiratory, thoracic and mediastinal disorders     
Respiratory symptoms   12/32 (37.50%)  15 9/32 (28.13%)  9
Skin and subcutaneous tissue disorders     
Dermatological symptoms   4/32 (12.50%)  5 0/32 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Faith Dickerson
Organization: Sheppard Pratt
Phone: 410-938-4359
EMail: fdickerson@sheppardpratt.org
Layout table for additonal information
Responsible Party: Faith Dickerson, Sheppard Pratt Health System
ClinicalTrials.gov Identifier: NCT02810964    
Other Study ID Numbers: SMRI/SPHS: 2016-01
First Submitted: June 14, 2016
First Posted: June 23, 2016
Results First Submitted: April 22, 2021
Results First Posted: July 27, 2021
Last Update Posted: July 27, 2021