None listed
Conditions
Brief summary
This study is to see if Benzoic acid is an acceptable add-on treatment for people who have Schizophrenia, have not responded to usual treatment, and have been stable for three months. Benzoic acid is a food additive, It is frequently used in foods such as fizzy drinks, soy sauce, and preserved fish as a preservative, and has been regarded as safe for this purpose. Benzoic acid has been tested as an add-on treatment in people with Schizophrenia in a clinical trial and it improved their symptoms when compared to placebo (an inactive tablet). No one has used this in people who do not respond to their usual medications. Before we consider doing a large study to see if this medication will help, we want to see if it is truly safe and acceptable to people who may be asked to take it, particularly if they are taking other medications.
Interventions
This is a 3 period, open-label study of Benzoic Acid (BA) added on to established antipsychotic medication in patients with chronic schizophrenia, who are symptomatic but stable.
The 3 periods are 1: baseline, with no study medication administered (2 weeks); 2: treatment with openlabel BA
500mg capsules, given twice daily (12 weeks); and 3: 4 weeks followup, where no further sodium benzoate is administered.
We will be dispensing pills weekly and asking participants to bring pills back to the n
This is a 3 period, open-label study of Benzoic Acid (BA) added on to established antipsychotic medication in patients with chronic schizophrenia, who are symptomatic but stable. The 3 periods are 1: baseline, with no study medication administered (2 weeks); 2: treatment with openlabel BA 500mg capsules, given twice daily (12 weeks); and 3: 4 weeks followup, where no further sodium benzoate is administered. We will be dispensing pills weekly and asking participants to bring pills back to the next visit to monitor adherence. Up to 24 participants will be enrolled. Because of its openlabel design, participant numbers have been chosen pragmatically. Participants will be established on antipsychotic medication for >3 months prior to baseline. With the exception of clozapine, any other antipsychotic medication (oral or depot) is permitted. Because this population are more likely to either be on multiple medications or medications with a significant side effect burden , previous studies in a non treatment resistant population will not be applicable: as this is a proof-of-concept trial, we have not included a control group.
Sponsors
Univeristy of Otago
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. A clinical diagnosis of Schizophrenia, confirmed by a structured diagnostic interview. 2. Have a body mass index between 18 and 35 (that is, not underweight or markedly overweight) 3. Have had no major change in their symptoms for three months. 4. Have moderate to severe current symptom
Exclusion criteria
1. You are pregnant or are intending to become pregnant. 2. Have a history of alcohol or drug dependance. 3. Have a history of epilepsy, head injury, or a neurological disorder. 4. If participating in the trial would place you at unacceptable risk. 5. If you are considered highly likely to not take any medications, as part of the study or not.
Outcome results
None listed