Psychiatric Centre Copenhagen, Copenhagen University, Faculty of Health Sciences, Copenhagen, Denmark.
Trials. 2011 Mar 10;12:72. doi: 10.1186/1745-6215-12-72.
The Danish OPUS I trial randomized 547 patients with first-episode psychosis to a two-year early-specialised assertive treatment programme (OPUS) versus standard treatment. The two years OPUS treatment had significant positive effects on psychotic and negative symptoms, secondary substance abuse, treatment adherence, lower dosage of antipsychotic medication, and a higher treatment satisfaction. However, three years after end of the OPUS treatment, the positive clinical effects were not sustained, except that OPUS-treated patients were significantly less likely to be institutionalised compared with standard-treated patients. The major objective of the OPUS II trial is to evaluate the effects of five years of OPUS treatment versus two years of OPUS treatment.
The OPUS II trial is designed as a randomized, open label, parallel group trial with blinded outcome assessment. Based on our sample size estimation, 400 patients treated in OPUS for two years will be randomized to further three years of OPUS treatment versus standard treatment. The specialized assertive OPUS treatment consists of three core elements: assertive community treatment, psycho-educational family treatment, and social skills training.
It has been hypothesized that there is a critical period from onset up to five years, which represents a window of opportunity where a long-term course can be influenced. Extending the specialized assertive OPUS treatment up to five years may allow the beneficial effects to continue beyond the high-risk period, through consolidation of improved social and functional outcome.
Clinical Trial.gov NCT00914238.
丹麦 OPUS I 试验将 547 名首发精神病患者随机分为两年期早期专业强化治疗方案（OPUS）组和标准治疗组。OPUS 治疗两年对精神病和阴性症状、继发物质滥用、治疗依从性、抗精神病药物剂量降低以及治疗满意度均有显著积极影响。然而，OPUS 治疗结束 3 年后，阳性临床疗效并未持续，除了 OPUS 治疗组患者与标准治疗组患者相比，住院率显著降低。OPUS II 试验的主要目的是评估 5 年 OPUS 治疗与 2 年 OPUS 治疗的效果。
OPUS II 试验设计为随机、开放标签、平行组试验，结局评估设盲。根据我们的样本量估计，2 年 OPUS 治疗的 400 名患者将被随机分为进一步的 3 年 OPUS 治疗和标准治疗。专业强化 OPUS 治疗包括三个核心要素：强化社区治疗、心理教育家庭治疗和社交技能训练。
有人假设，从发病到五年期间存在一个关键时期，这是一个可以影响长期病程的机会窗口。将强化 OPUS 治疗延长至 5 年，可能通过巩固改善的社会和功能结局，使有益效果持续到高风险期之后。
ClinicalTrials.gov NCT00914238。
