Dose finding clinical trial of sodium benzoate in people with treatment refractory schizophrenia

Phase 2

Recruiting

Conditions: Treatment refractory schizophrenia
Schizophrenia
Mental Health - Schizophrenia

Registration Number: ACTRN12621000327886

Lead Sponsor: QIMR Berghofer Medical Institute of Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 52

Inclusion Criteria

1.Aged between 18 and 64 years (inclusive).
2.Fulfil the DSM-IV criteria practice for schizophrenia, based on the Diagnostic Interview for Psychosis.
3.Have had the diagnosis of schizophrenia for at least 12 months duration
4.Have a Positive and Negative Syndrome Scale (PANSS) total score greater than or equal to 70
5.Have received antipsychotic medications for a period of at least one continuous month prior to assessment for the study and remained symptomatic despite taking antipsychotic therapy
6.Agree to participate, has capacity to consent and able to follow the study instructions and procedures.

Exclusion Criteria

1.Known allergies to sodium benzoate (E211) or any part of the formulation of the
investigational product.
2.Suspected allergies or known adverse reactions to food preservatives in general.
3.Comorbid physical illnesses that would impair the participants’ ability to complete the trial.
4.People who are unable to understand or communicate in English.
5.For female participant, those currently pregnant, or planning to become pregnant or lactating during the study period.
6.Inability to follow the study instructions and procedures.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS) total score[ baseline (week 0), and weeks 2, 4, and 6<br>Primary timepoint 6 weeks]

Secondary Outcome Measures

Name	Time	Method
Positive subscale of PANSS[ baseline (week 0), and weeks 2, 4, and 6<br>];<br>Global Assessment of Function (GAF)[ baseline (week 0), and weeks 2, 4, and 6<br>];Clinical Global Impression (CGI)[ baseline (week 0), and weeks 2, 4, and 6<br>];<br>Overall patient impression of treatment-related change as measured by Patient Global Impression (PGI)- Improvement<br>[ baseline (week 0), and weeks 2, 4, and 6<br>];Safety and tolerablity of the three doses (1000mg daily, 2000mg daily or 4000mg daily) of sodium benzoate under investigation measured by participant self-report of adverse events, [ baseline (week 0), and weeks 2, 4, and 6<br>];Negative subscale of PANSS[ baseline (week 0), and weeks 2, 4, and 6<br>];General psychopathology subscale of PANSS<br>[ baseline (week 0), and weeks 2, 4, and 6<br><br>]