Abstract
Objective To evaluate the effect of combination treatment by psychological intervention and a new atypical antipsychotic Paliperidone extended-release tablets(paliperidone ER)on first-episode schizophrenic out-patients.Methods All 62 patients diagnosed as first-episode schizophrenia by DSM-Ⅳ were randomly allocated into,combination treatment group and control group,for a 12-month treatment study.The combination treatment group was treated by paliperidone ER once a day and psychological counseling once a month,while the control group was treated only by paliperidone ER.The efficacy and social function were assessed by Positive and Negative Syndrome Scale(PANSS)and Personal and Social Performance Scale(PSP)individually at baseline,and following 1,3,6,9,12 months.The remission rate was calculated at the end of the 3rd,6th,9th month.The safety and tolerability were assessed using Barnes Akathisia Scale(BARS),extrapyramidal side effects scale(SAS)and involuntary movement scale(AIMS).Results Twenty-seven patients of combination treatment group and seventeen patients of the control group completed the trial with the discontinuation rate 12.9% and 45.2%,respectively.The difference between the above two groups was statistically significant(P<0.05).The mean total score of PANSS and the PSP of the both groups were significantly improved(P<0.05)after treatment.PANSS total score reduced more than 30% compared with baseline,and PSP total score increased more than 7.The remission rate of combination treatment group was 74.2%,51.6% and 67.7% at the end of 3rd,6th,and 9th month,which was better than the control group(45.2%,38.7% and 38.7%)(P<0.05).Both incidence and types of adverse events were almost same between the two groups.The major adverse events were extrapyramidal symptoms,tachycardia,gastrointestinal discomfort and akathisia.Conclusion Paliperidone ER treatment combined with psychological intervention on first-episode schizophrenia out-patients can improve their treatment compliance by reducing the discontinuation rate.And this combination treatment can increase the remission rate and improve social functioning of the patients. Key words: Schizophrenia; Psychological intervention; Paliperidone; Remission rate; Social Functioning
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