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 < .001, compared with the placebo. HDRS scores and its changes, ESRS score, and frequency of other side effects were not significantly different between the two groups. CONCLUSIONS:Citicoline add-on therapy to risperidone can effectively improve the primary negative symptoms of patients with schizophrenia.
RCT Entities:
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 < .001, compared with the placebo. HDRS scores and its changes, ESRS score, and frequency of other side effects were not significantly different between the two groups. CONCLUSIONS:Citicoline add-on therapy to risperidone can effectively improve the primary negative symptoms of patients with schizophrenia.