In short
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.
Key points
- SODIUM BENZOATE is being studied in one authorised Phase 4 trial in adults with refractory schizophrenia. The study tests it as an add-on to clozapine and compares it with placebo. Researchers want to find the best dose in Part 1 and then test that dose in Part 2. The main result is the change in PANSS total score after 8 weeks of randomized treatment. The trial plans to enroll 278 people and focuses on residual symptoms that remain despite treatment.
Trial overview
The trial NCT03094429 is an interventional study of SODIUM BENZOATE in adults with refractory schizophrenia. It is designed as an add-on study with clozapine and compares SODIUM BENZOATE with placebo.
The study status is Authorised, and the planned enrollment is 278 participants.
Study design and phases
This is an adaptive, double-blind, randomized, placebo-controlled, two-part, dose-finding, multi-center study. 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.
The trial is listed as Phase 4. 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. In Part 2, the selected dose is compared with placebo again to test effectiveness with clozapine.
Who can participate
The study is for adults with refractory schizophrenia. The trial summary says it focuses on people who still have residual symptoms while taking clozapine.
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.
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. Baseline means the starting point before the trial treatment begins.
PANSS is a symptom score used in schizophrenia studies to track changes in overall illness severity. A lower score after treatment may suggest improvement, but the trial data only states that this score is being measured.
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. The researchers want to see which dose works best for improving residual symptoms in adults with refractory schizophrenia.
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. Part 2 then tests the chosen optimal dose against placebo to confirm its effect.
Key terms explained
Placebo-controlled means the study compares the active study treatment with a look-alike treatment that has no active medicine.
Randomized means participants are assigned to study groups by chance.
Double-blind means neither the participants nor the study team know who is receiving which treatment during the study.
Residual symptoms are symptoms that remain even after treatment has started.
Refractory schizophrenia means schizophrenia that does not respond well enough to standard treatment.