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SODIUM BENZOATE

Clinical trials are studying SODIUM BENZOATE as an add-on treatment for adults with refractory schizophrenia. These studies look at safety, effectiveness, and the best dose when used with clozapine. The main goal is to see whether it can improve leftover symptoms that remain despite treatment.

Table of contents

Trial overview

The trial NCT03094429 is an interventional study of SODIUM BENZOATE in adults with refractory schizophrenia.[1] It is designed as an add-on study with clozapine and compares SODIUM BENZOATE with placebo.[1]

The study status is Authorised, and the planned enrollment is 278 participants.[1]

Study design and phases

This is an adaptive, double-blind, randomized, placebo-controlled, two-part, dose-finding, multi-center study.[1] Adaptive means the study plan can be adjusted based on early results, while dose-finding means it tries to identify the best dose for the later part of the trial.[1]

The trial is listed as Phase 4.[1] In Part 1, the study compares 1000 mg/day and 2000 mg/day with placebo to evaluate dose-response and choose the optimal dose for Part 2.[1] In Part 2, the selected dose is compared with placebo again to test effectiveness with clozapine.[1]

Who can participate

The study is for adults with refractory schizophrenia.[1] The trial summary says it focuses on people who still have residual symptoms while taking clozapine.[1]

Based on the trial data, participation is meant for patients whose symptoms have not fully improved with current treatment, rather than for people with a different condition.[1]

What is being measured

The primary outcome is the mean change from baseline in the Positive and Negative Syndrome Scale, or PANSS, total score after 8 weeks of randomized treatment.[1] Baseline means the starting point before the trial treatment begins.[1]

PANSS is a symptom score used in schizophrenia studies to track changes in overall illness severity.[1] A lower score after treatment may suggest improvement, but the trial data only states that this score is being measured.[1]

What the study is trying to find

Part 1 aims to compare SODIUM BENZOATE doses of 1000 mg/day and 2000 mg/day against placebo when added to clozapine.[1] The researchers want to see which dose works best for improving residual symptoms in adults with refractory schizophrenia.[1]

Part 1 also includes a sample size re-assessment, which means the team checks whether the planned number of participants is enough to continue into Part 2.[1] Part 2 then tests the chosen optimal dose against placebo to confirm its effect.[1]

Key terms explained

Placebo-controlled means the study compares the active study treatment with a look-alike treatment that has no active medicine.[1]

Randomized means participants are assigned to study groups by chance.[1]

Double-blind means neither the participants nor the study team know who is receiving which treatment during the study.[1]

Residual symptoms are symptoms that remain even after treatment has started.[1]

Refractory schizophrenia means schizophrenia that does not respond well enough to standard treatment.[1]

Trial ID Phase Condition studied Status Enrollment
NCT03094429 Phase 4 Treatment for Refractory Schizophrenia in Adults Authorised 278

FAQ

  • What is being studied in the SODIUM BENZOATE trial? The trial is studying SODIUM BENZOATE as an add-on therapy with clozapine. It compares SODIUM BENZOATE with placebo to see if it helps improve residual symptoms of refractory schizophrenia.
  • Who can join this trial? The study is for adults with refractory schizophrenia. It focuses on people who still have symptoms even while taking clozapine.
  • What phase is the trial? This is a Phase 4 study. It is also an adaptive, randomized, double-blind, placebo-controlled trial with two parts.
  • What outcomes are the researchers measuring? The main outcome is the change in PANSS total score after 8 weeks of randomized treatment. PANSS is a symptom rating scale used in schizophrenia research.
  • How many people are planned for the study? The trial plans to enroll 278 participants. The study also includes a sample size re-assessment in Part 1 to help decide how many people are needed for Part 2.

Ongoing Clinical Trials on SODIUM BENZOATE

  • Study on Sodium Benzoate and Clozapine for Adults with Refractory Schizophrenia Symptoms

    Recruiting

    1 1
    Investigated drugs:
    Poland

Glossary

  • Refractory schizophrenia: A form of schizophrenia that does not respond well enough to standard treatment.
  • Residual symptoms: Symptoms that remain even after treatment has started.
  • Clozapine: A medicine already being used in the study as the background treatment.
  • Add-on therapy: A treatment added to an existing medicine to see if it improves results.
  • Placebo: A treatment with no active study medicine, used for comparison.
  • Randomized: Participants are put into study groups by chance.
  • Double-blind: Neither the participants nor the study team know who gets which treatment during the trial.
  • Dose-finding: A part of the study that looks for the best amount of study medicine to use.
  • PANSS: A rating scale called the Positive and Negative Syndrome Scale, used to measure schizophrenia symptoms.
  • Primary outcome: The main result the researchers are trying to measure.

References