Neurotransmitters in Treatment Resistant Schizophrenia Patients With add-on Sodium Benzoate

Launched by NATIONAL CHENG-KUNG UNIVERSITY HOSPITAL · Mar 29, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment for patients with treatment-resistant schizophrenia (TRS), a condition where standard medications do not adequately help with symptoms. The study will explore the use of sodium benzoate, a substance that may affect brain chemicals involved in mood and thought processes. Researchers hope to find out if sodium benzoate can improve symptoms in these patients and to identify which individuals might respond best to this treatment. The trial will involve 90 participants who will receive either sodium benzoate or a placebo (a treatment with no active ingredients) over eight weeks.

To be eligible for this trial, participants must have a diagnosis of schizophrenia or schizoaffective disorder and have not responded well to at least two different antipsychotic medications. They should also have experienced symptoms for at least six months without any significant improvement. Participants will undergo various assessments to measure how well the treatment is working, including brain scans and tests of thinking abilities. It’s important to note that the trial is not yet recruiting participants, and anyone interested should check for updates in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Fulfil the DSM5 criteria for schizophrenia or schizoaffective disorder
• • 2. Research criteria for treatment resistance: little or no symptomatic response to multiple (at least two) antipsychotic treatment of an adequate duration (at least 6 weeks) and adequate doses (equivalent to at least 600 milliequivalent (meq)/day of chlorpromazine)
• • 3. 6 month period without remission (i.e. ≥4 item-score for the positive symptoms on PANSS scale , especially delusional thoughts, conceptual disorganisation, excitements, grandiosity, hallucinatory behaviour, excitement, persecution, and hostility)
• • 4. The persistence of illness was defined as a score of ≥4 (moderately ill) on the severity of illness subscale of the Clinical Global Impression scale (CGI-S), and a lack of stable period of good social occupational function.
• Exclusion Criteria:
• • 1. Current or previous diagnosis of concurrent DSM-5 disorder due to active medical problems, known neurological disease, or a contraindication to MRI scanning
• • 2. Current diagnosis of substance-related disorder
• • 3. Any acute or chronic medical condition
• • 4. History of head trauma or neurological diseases.