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The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial

trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1908-5

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The study by Lane et al. was based on 52 patients with chronic schizophrenia [12]. They reported a Cohen¡¦s effect size (d) of 1.53. Our patients (with early psychosis) tend to have slightly lower mean PANSS total scores (65.0), with a standard deviation of 14.3 units and it is anticipated that the effect size will be smaller in this group.

With an alpha value of 0.05, and power of 0.8,

we wish to be able to confidently detect a difference in mean PANSS total score of at least 7 units.

This will require 66 participants per group (n = 132). Over a 12-week period we predict an attrition rate of 15%. Thus, we will need to randomize approximately 160 subjects.

P values will be based on two-tailed tests with significance levels of 0.05.

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Protocol update and statistical analysis plan for CADENCE-BZ: a randomized clinical trial to assess the efficacy of sodium benzoate as an adjunctive treatment in early psychosis

trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3232-8

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The last participant was recruited in August 2018 with the final follow-up visit anticipated to be completed in October 2018.

The final participants are currently completing the study and the results will be published in the near future.

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Our sample size was reduced from 160 to 100 after we adjusted our SAP. We recalculated our sample size by revising our assumptions regarding the correlations for a variety of covariance structures and the number of repeated measures.

Using a two-tailed test with alpha set at 0.05 and 90% power, to detect a minimum clinical meaningful difference in total PANSS score of at least 5 units (SD = 14.3) between both treatment arms, we determined that we needed a sample of 39 persons in each group.

This assumes the correlation between baseline and follow-up measurements is at least 0.6 and the correlation between various follow-up measurements is at most 0.5. Over a 12-week period, we predicted an attrition rate of 20%.

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