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Trial from ANZCTR

The Efficacy of Sodium Benzoate as an Adjunctive Treatment in Early Psychosis

  • Recruitment status at the time of last update
    Active, not recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 27/8/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12615000187549

Date registered

26 February 2015

Health condition

Early psychosis (including schizophrenia, schizophreniform psychosis, delusional disorder, bipolar disorder, psychosis not otherwise specified)

Recruitment countries

Australia

Recruitment site location(s) (State)

Queensland

Recruitment status

Active, not recruiting

Anticipated date of first participant enrolment

17 August 2015

Ethics application status

Approved

Brief summary

The study will be a randomised, placebo-controlled, double-blind parallel-group trial over a 12 week period. The primary objective is to examine the clinical efficacy of the add-on treatment of sodium benzoate for persistent symptoms in patients with early psychosis. Specifically, it is hypothesised, that participants allocated to the active arm (1000mg (500mg twice daily)) Sodium Benzoate treatment will have significant reductions in the Positive and Negative Syndrome Scale (PANSS) total score at week 12 compared to individuals taking placebo.

Eligibility

Key inclusion criteria

1. Aged between 15 and 45 years (inclusive).
2. Fulfil the DSM-IV criteria practice for broadly defined early psychosis, based on the Diagnostic Interview for Psychosis. This includes diagnoses such as schizophrenia, schizophreniform psychosis, delusional disorder, bipolar disorder, psychosis not otherwise specified.
3. Have had the onset of a psychotic disorder within the last two years
4. Have received antipsychotic medications for a period of at least one continuous month within the above two year period.
5. Have a Positive and Negative Syndrome Scale (PANSS) total score of at least 55.
6. Agree to participate, has capacity to consent and able to follow the study instructions and procedures.
7. If under 18 years of age, a parent or legal guardian consents to the young person’s participation.

Minimum age

15 Years

Maximum age

45 Years

Gender

Both males and females

Key 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.

Contact details and further information

Primary Sponsor

Type: University
Name: The University of Queensland
Address: St Lucia, QLD 4072
Country: Australia

Contact person for information and recruitment

Prof John McGrath
Queensland Brain Institute
University of Queensland
St Lucia, QLD, 4072 Australia
Australia
+61 7 3346 6372
j.mcgrath@uq.edu.au