Citicoline (CDP‐choline) add‐on therapy to risperidone for treatment of negative symptoms in patients with stable schizophrenia: A double‐blind, randomized placebo‐controlled trial

Objective We aimed to evaluate the efficacy and tolerability of citicoline add‐on therapy in treatment of negative symptoms in patients with stable schizophrenia. Methods In a double‐blind and placebo‐controlled study, patients with stable schizophrenia (DSM‐5) were randomized to receive either 2,500 mg/day citicoline or placebo in addition to risperidone for 8 weeks. The patients were assessed using the positive and negative syndrome scale (PANSS), the extrapyramidal symptom rating scale (ESRS), and Hamilton depression rating scale (HDRS). The primary outcome was the difference in PANSS negative subscale score reduction from baseline to week 8 between the citicoline and the placebo groups. Results Sixty‐six individuals (out of 73 enrolled) completed the trial. The citicoline group demonstrated significantly greater improvement in negative scores, F(1.840, 118.360) = 8.383, p = .001, as well as general psychopathology, F(1.219, 78.012) = 6.636, p = .008; change in general psychopathology did not remain significant after adjustment, and total PANSS scores, F(1.633, 104.487) = 15.400, p