Sodium benzoate added to standard treatment for treatment-resistant schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, randomized, double-blind, placebo-controlled trial enrolling 90 participants with treatment-resistant schizophrenia from three hospitals. Participants are assigned 2:1 to receive either sodium benzoate 2 grams per day or placebo for six weeks, in addition to their ongoing antipsychotic treatment. The trial aims to see if sodium benzoate improves overall symptoms (as measured by PANSS) and cognition in responders and non-responders alike, with response defined as a 20% reduction in PANSS total score after six weeks. The study extends prior pilot data and uses a two-year design with two subgroups within the treatment arm.

Why it matters

Who can join: the full rules

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.

Where it's running

• Taichung Veterans General Hospital Chiayi Branch
  Chiayi City, Taiwan Recruiting

Study contacts

• Study coordinator: Yen-Kuang Yang, Dr
• Email: ykyang@mail.ncku.edu.tw
• Phone: +886-6-2353535

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Clubhouse-based care for people with schizophrenia and related conditions

  This study tests whether the Clubhouse Model of psychosocial rehabilitation helps thinking skills and daily function more than usual community mental health care in adults with schizophrenia, schizoaffective disorder, or schizophreniform disorders.

  Recruiting Case Western Reserve University · Cleveland, Ohio · NCT07006935

• Using Lumateperone to improve motivation in patients with schizophrenia and psychosis

  This study is testing if Lumateperone can help people with schizophrenia or schizoaffective disorders feel more motivated and less apathetic.

  Recruiting Phase 3 Louisiana State University Health Sciences Center Shreveport · Shreveport, Louisiana · NCT06482554

• Effects of lumateperone on metabolic side effects in patients taking clozapine for schizophrenia

  This study is testing if adding lumateperone to clozapine treatment can help people with schizophrenia reduce weight gain and cholesterol issues caused by their medication.

  Recruiting Phase 4 University of Massachusetts, Worcester · Worcester, Massachusetts · NCT06174116

• Using iTBS to Improve Social Cognition in People with Psychosis

  This study is testing whether a new brain stimulation treatment can help people with schizophrenia improve their social skills and thinking.

  Recruiting Northwell Health · Glen Oaks, New York · NCT06118268

• Virtual reality program to improve cognitive skills in people with psychosis

  This study tests whether a virtual reality program can help people with psychosis improve their thinking and social skills over six weeks.

  Recruiting The Royal Ottawa Mental Health Centre · Ottawa, Ontario · NCT05973110

• Examining the effects of combined therapy for schizophrenia

  This study is testing whether combining two therapies, one for managing thoughts and another for improving cognitive skills, can help people with schizophrenia do better in their daily lives compared to using just one of the therapies.

  Recruiting at 2 sites University of Toronto · Scarborough Village, Ontario and 1 other locations · NCT05731414

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.