Cadence discovery: study protocol for a dose-finding and mechanism of action clinical trial of sodium benzoate in people with treatment-refractory schizophrenia
Abstract Background Schizophrenia is a persistent psychotic disorder often accompanied by severe disability and premature mortality. New pharmacological treatments are urgently needed. Sodium benzoate, a common food preservative holds potential to be an effective, accessible treatment for schizophre...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2021-12-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05890-6 |
| _version_ | 1819008859360985088 |
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| author | Andrea Baker Lachlan Clarke Peter Donovan Jacobus P. J. Ungerer Gunter Hartel George Bruxner Luca Cocchi Anne Gordon Vikas Moudgil Gail Robinson Digant Roy Ravinder Sohal Emma Whittle James G. Scott |
| author_facet | Andrea Baker Lachlan Clarke Peter Donovan Jacobus P. J. Ungerer Gunter Hartel George Bruxner Luca Cocchi Anne Gordon Vikas Moudgil Gail Robinson Digant Roy Ravinder Sohal Emma Whittle James G. Scott |
| author_sort | Andrea Baker |
| collection | DOAJ |
| description | Abstract Background Schizophrenia is a persistent psychotic disorder often accompanied by severe disability and premature mortality. New pharmacological treatments are urgently needed. Sodium benzoate, a common food preservative holds potential to be an effective, accessible treatment for schizophrenia, though the optimal dosing and mechanism of action of the compound requires further investigation. Methods Individuals with persistent treatment-refractory schizophrenia (n=52) will be recruited. Patients will be randomised in a 1:1:1:1 ratio to receive treatment of one of three active doses (1000, 2000 or 4000 mg daily) of sodium benzoate or placebo for 6 weeks duration. The primary outcome measurement is change in the Positive and Negative Syndrome Scale (PANSS) total score. Secondary outcome measurements are PANSS subscales, Global Assessment of Function (GAF), Clinical Global Impression (CGI) and Patient Global Impression (PGI-I). Change in concentrations of peripheral amino acids (D-alanine, L-alanine, D-serine, L-serine, glycine and glutamate), plasma sodium benzoate, plasma catalase, 3-nitrotyrosine, malondialdehyde and high-sensitivity C-reactive protein (hs-CRP) will be determined as tertiary measures. Discussion This trial seeks to build upon previous research indicating potential efficacy of sodium benzoate for reduction of symptoms in individuals with treatment-refractory schizophrenia. The trial aims to improve the understanding of the mechanism of action of the compound. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621000327886 . Registered on 23 March 2021. |
| first_indexed | 2024-12-21T00:47:10Z |
| format | Article |
| id | doaj.art-ef44251800c14da396665ea09e52f817 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-21T00:47:10Z |
| publishDate | 2021-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-ef44251800c14da396665ea09e52f8172022-12-21T19:21:30ZengBMCTrials1745-62152021-12-0122111010.1186/s13063-021-05890-6Cadence discovery: study protocol for a dose-finding and mechanism of action clinical trial of sodium benzoate in people with treatment-refractory schizophreniaAndrea Baker0Lachlan Clarke1Peter Donovan2Jacobus P. J. Ungerer3Gunter Hartel4George Bruxner5Luca Cocchi6Anne Gordon7Vikas Moudgil8Gail Robinson9Digant Roy10Ravinder Sohal11Emma Whittle12James G. Scott13QIMR Berghofer Medical Research InstituteQIMR Berghofer Medical Research InstituteFaculty of Medicine, The University of QueenslandSchool of Biomedical Sciences, The University of QueenslandQIMR Berghofer Medical Research InstituteMetro North Mental Health Service, Caboolture HospitalQIMR Berghofer Medical Research InstituteMetro North Mental Health Service, The Prince Charles HospitalMetro North Mental Health Service, Royal Brisbane and Women’s HospitalFaculty of Medicine, The University of QueenslandMetro North Mental Health Service, The Prince Charles HospitalMetro North Mental Health Service, Royal Brisbane and Women’s HospitalClinical Pharmacology, Royal Brisbane and Women’s HospitalQIMR Berghofer Medical Research InstituteAbstract Background Schizophrenia is a persistent psychotic disorder often accompanied by severe disability and premature mortality. New pharmacological treatments are urgently needed. Sodium benzoate, a common food preservative holds potential to be an effective, accessible treatment for schizophrenia, though the optimal dosing and mechanism of action of the compound requires further investigation. Methods Individuals with persistent treatment-refractory schizophrenia (n=52) will be recruited. Patients will be randomised in a 1:1:1:1 ratio to receive treatment of one of three active doses (1000, 2000 or 4000 mg daily) of sodium benzoate or placebo for 6 weeks duration. The primary outcome measurement is change in the Positive and Negative Syndrome Scale (PANSS) total score. Secondary outcome measurements are PANSS subscales, Global Assessment of Function (GAF), Clinical Global Impression (CGI) and Patient Global Impression (PGI-I). Change in concentrations of peripheral amino acids (D-alanine, L-alanine, D-serine, L-serine, glycine and glutamate), plasma sodium benzoate, plasma catalase, 3-nitrotyrosine, malondialdehyde and high-sensitivity C-reactive protein (hs-CRP) will be determined as tertiary measures. Discussion This trial seeks to build upon previous research indicating potential efficacy of sodium benzoate for reduction of symptoms in individuals with treatment-refractory schizophrenia. The trial aims to improve the understanding of the mechanism of action of the compound. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621000327886 . Registered on 23 March 2021.https://doi.org/10.1186/s13063-021-05890-6SchizophreniaAdjunctiveTreatment refractorySodium benzoateInterventionRCT |
| spellingShingle | Andrea Baker Lachlan Clarke Peter Donovan Jacobus P. J. Ungerer Gunter Hartel George Bruxner Luca Cocchi Anne Gordon Vikas Moudgil Gail Robinson Digant Roy Ravinder Sohal Emma Whittle James G. Scott Cadence discovery: study protocol for a dose-finding and mechanism of action clinical trial of sodium benzoate in people with treatment-refractory schizophrenia Trials Schizophrenia Adjunctive Treatment refractory Sodium benzoate Intervention RCT |
| title | Cadence discovery: study protocol for a dose-finding and mechanism of action clinical trial of sodium benzoate in people with treatment-refractory schizophrenia |
| title_full | Cadence discovery: study protocol for a dose-finding and mechanism of action clinical trial of sodium benzoate in people with treatment-refractory schizophrenia |
| title_fullStr | Cadence discovery: study protocol for a dose-finding and mechanism of action clinical trial of sodium benzoate in people with treatment-refractory schizophrenia |
| title_full_unstemmed | Cadence discovery: study protocol for a dose-finding and mechanism of action clinical trial of sodium benzoate in people with treatment-refractory schizophrenia |
| title_short | Cadence discovery: study protocol for a dose-finding and mechanism of action clinical trial of sodium benzoate in people with treatment-refractory schizophrenia |
| title_sort | cadence discovery study protocol for a dose finding and mechanism of action clinical trial of sodium benzoate in people with treatment refractory schizophrenia |
| topic | Schizophrenia Adjunctive Treatment refractory Sodium benzoate Intervention RCT |
| url | https://doi.org/10.1186/s13063-021-05890-6 |
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