N-Acetylcysteine and a Specialized Preventive Intervention for Individuals at High Risk for Psychosis: A Randomized Double-Blind Multicenter Trial.

Wasserthal, Sven; Muthesius, Ana; Hurlemann, René; Ruhrmann, Stephan; Schmidt, Stefanie J; Hellmich, Martin; Schultze-Lutter, Frauke; Klosterkötter, Joachim; Müller, Hendrik; Meyer-Lindenberg, Andreas; Poeppl, Timm B; Walter, Henrik; Hirjak, Dusan; Koutsouleris, Nikolaos; Fallgatter, Andreas J; Bechdolf, Andreas; Brockhaus-Dumke, Anke; Mulert, Christoph; Philipsen, Alexandra and Kambeitz, Joseph (2024). N-Acetylcysteine and a Specialized Preventive Intervention for Individuals at High Risk for Psychosis: A Randomized Double-Blind Multicenter Trial. Schizophrenia Bulletin Open, 5(1), sgae005. Oxford University Press 10.1093/schizbullopen/sgae005

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BACKGROUND AND HYPOTHESIS

Clinical high risk for psychosis (CHR-P) offers a window of opportunity for early intervention and recent trials have shown promising results for the use of N-acetylcysteine (NAC) in schizophrenia. Moreover, integrated preventive psychological intervention (IPPI), applies social-cognitive remediation to aid in preventing the transition to the psychosis of CHR-P patients.

STUDY DESIGN

In this double-blind, randomized, controlled multicenter trial, a 2 × 2 factorial design was applied to investigate the effects of NAC compared to placebo (PLC) and IPPI compared to psychological stress management (PSM). The primary endpoint was the transition to psychosis or deterioration of CHR-P symptoms after 18 months.

STUDY RESULTS

While insufficient recruitment led to early trial termination, a total of 48 participants were included in the study. Patients receiving NAC showed numerically higher estimates of event-free survival probability (IPPI + NAC: 72.7 ± 13.4%, PSM + NAC: 72.7 ± 13.4%) as compared to patients receiving PLC (IPPI + PLC: 56.1 ± 15.3%, PSM + PLC: 39.0 ± 17.4%). However, a log-rank chi-square test in Kaplan-Meier analysis revealed no significant difference of survival probability for NAC vs control (point hazard ratio: 0.879, 95% CI 0.281-2.756) or IPPI vs control (point hazard ratio: 0.827, 95% CI 0.295-2.314). The number of adverse events (AE) did not differ significantly between the four groups.

CONCLUSIONS

The superiority of NAC or IPPI in preventing psychosis in patients with CHR-P compared to controls could not be statistically validated in this trial. However, results indicate a consistent pattern that warrants further testing of NAC as a promising and well-tolerated intervention for CHR patients in future trials with adequate statistical power.

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