PMID- 25549697 OWN - NLM STAT- MEDLINE DCOM- 20160106 LR - 20181202 IS - 1502-4725 (Electronic) IS - 0803-9488 (Linking) VI - 69 IP - 6 DP - 2015 Aug TI - Effects of paliperidone extended release on functioning level and symptoms of patients with recent onset schizophrenia: An open-label, single-arm, flexible-dose, 12-months follow-up study. PG - 426-32 LID - 10.3109/08039488.2014.996252 [doi] AB - BACKGROUND: Response to antipsychotic treatment is better in the early stages of schizophrenia. AIMS: The primary objective of this non-randomized, single-arm, multicenter clinical trial was to explore the response to treatment and safety of a flexible dose of paliperidone (mean = 6.42 mg/day) in patients with recent onset schizophrenia (< 3 years after the first episode/hospitalization). METHODS: Severity of clinical symptoms was evaluated by the Positive and Negative Syndrome Scale (PANSS), functioning was assessed using the Global Assessment of Functioning (GAF) scale and the Personal and Social Performance Scale (PSP). RESULTS: In a total of 85 patients enrolled, 80 patients were eligible. Total PSP score at baseline (50.2 +/- 11.6) increased at all visits. Total PSP score was 65.4 +/- 12.1 at month 12 (P < 0.001). GAF scores were significantly higher at all visits compared with baseline (P = 0.001). It was 62.4 +/- 12.5 with an increase of 42.9% at month 12 (P < 0.001). PANSS Positive and Negative subscales and General psychopathology subscale scores showed significant reductions beginning with month 3 and were 11.9 +/- 3.8 (29.3%; P < 0.001), 13.7 +/- 5.6 (27.3% P < 0.001) and 27.8 +/- 7.1 (23.2%; P < 0.001) at month 12, respectively. Twelve patients (14.3%) had a serious adverse event. The most common adverse events were insomnia (17.9%), nausea (8.3%), akathisia (4.8%), anxiety (4.8%) and depression (4.8%). Body weight values at the end of the study were significantly higher compared with baseline. CONCLUSION: The present study demonstrates that flexible dose of paliperidone resulted in a significant improvement in functioning and reduction in symptoms in patients with recent onset schizophrenia. FAU - Ucok, Alp AU - Ucok A AD - Alp Ucok, M.D., Professor of Psychiatry, Istanbul University, Istanbul Faculty of Medicine , Istanbul , Turkey. FAU - Saka, Meram Can AU - Saka MC FAU - Bilici, Mustafa AU - Bilici M LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20141231 PL - England TA - Nord J Psychiatry JT - Nordic journal of psychiatry JID - 100927567 RN - 0 (Antipsychotic Agents) RN - 0 (Delayed-Action Preparations) RN - R8P8USM8FR (Paliperidone Palmitate) SB - IM MH - Adult MH - Antipsychotic Agents/adverse effects/*therapeutic use MH - Delayed-Action Preparations MH - Dose-Response Relationship, Drug MH - Drug Substitution MH - Female MH - Humans MH - Intention to Treat Analysis MH - Male MH - Paliperidone Palmitate/adverse effects/*therapeutic use MH - Psychiatric Status Rating Scales MH - Schizophrenia/diagnosis/*drug therapy MH - *Schizophrenic Psychology OTO - NOTNLM OT - Functioning OT - Paliperidone ER OT - Schizophrenia EDAT- 2015/01/01 06:00 MHDA- 2016/01/07 06:00 CRDT- 2015/01/01 06:00 PHST- 2015/01/01 06:00 [entrez] PHST- 2015/01/01 06:00 [pubmed] PHST- 2016/01/07 06:00 [medline] AID - 10.3109/08039488.2014.996252 [doi] PST - ppublish SO - Nord J Psychiatry. 2015 Aug;69(6):426-32. doi: 10.3109/08039488.2014.996252. Epub 2014 Dec 31.