A randomized, prospective, active-controlled study comparing intramuscular long-acting paliperidone palmitate versus oral antipsychotics in patients with schizophrenia at risk of violent behavior.

OBJECTIVE: Paliperidone palmitate (PP) is an effective long-acting antipsychotic injection, but its impact on the behavior of schizophrenia patients with dangerous tendencies requires further investigation. This study aims to explore the effects of long-term antipsychotic treatment on this population in the community. METHODS: This 49-week, randomized controlled trial was conducted across 21 communities in Wuhan and enrolled 134 schizophrenia patients at risk for violent behavior. With a fixed block size of 10, participants were randomly assigned to receive either intramuscular PP 1-month formulation (PP1M) or oral antipsychotic medication (OAP) at a 1:1 ratio. Changes in patients' risk for violent/aggressive behavior, family burden, social, and cognitive functioning were measured using VRAPP, MOAS, PANSS, FBS, PSP, and RBANS scales from baseline to endpoint. Longitudinal data from multiple repeated measures were analyzed using linear mixed-effects models. RESULTS: The study protocol was completed by 77.6% of the patients overall. Significant improvements were observed in the risk assessment scores, MOAS total score, PANSS total score, PSP total score, and FBS total score of patients in the PP1M group from baseline to the end of treatment (all P < 0.05). Importantly, compared to patients in the OAP group, the improvements in these measures were also significantly greater in the PP1M group. Commonly observed AEs, such as hyperprolactinemia (70.3% vs. 62.65%) and muscle tension (45.3% vs. 57.8%), were considered to be the PP-related AEs. Nonetheless, the differences between the two groups did not reach statistical significance, and no new safety concerns emerged. CONCLUSIONS: Our study suggests that PP long-acting injection (LAI) is a safe and effective treatment option for community-dwelling schizophrenia patients with impulsive violence and risky behaviors.

Prevalence and clinical correlates of psychotic depression in first-episode and drug-naïve outpatients with major depressive disorder in a Chinese Han population.

BACKGROUND: Few systemic studies of psychotic depression (PD) have been conducted in first-episode and drug-naïve (FEDN) patients. This study was to examine the prevalence of PD and its clinical correlates in a large sample of FEDN outpatients with major depressive disorder (MDD) in a Chinese Han population, which to our best knowledge has not been studied. METHODS: In this cross-sectional study, a total of 1718 FEDN MDD outpatients were recruited. All patients were rated on the positive symptom subscale of the Positive and Negative Syndrome Scale (PANSS) for psychotic symptoms, the 17-item Hamilton Depression Rating Scale (HAMD-17) for depression and Hamilton Anxiety Rating Scale (HAMA) for anxiety. RESULTS: The prevalence of PD was 10.0% (171/1718) in MDD patients. Compared to the non-PD patients, PD patients had significantly older age, lower educational levels, higher anxiety symptom score and were more likely to attempt suicide. Further logistic regression analysis indicated that PD was associated with older age, suicide attempt and comorbid anxiety (all p < 0.05). Multiple regression analyses showed that both HAMD and HAMA total scores were significantly associated with PANSS positive symptom subscale score. LIMITATIONS: Our cross-sectional study design does not show a direct causal relationship between psychiatric symptoms and related factors in patients with MDD. CONCLUSIONS: Our results suggest a high prevalence of PD in MDD patients in the acute early stage in a Chinese Han population, which is associated with demographic variables and clinical symptoms.