Five-Year Follow-up of a Randomized Multicenter Trial of Intensive Early Intervention vs Standard Treatment for Patients With a First Episode of Psychotic Illness

Bertelsen, Mette; Jeppesen, Pia; Petersen, Lone; Thorup, Anne; Øhlenschlæger, Johan; Quach, Phuong le; Christensen, Thomas; Krarup, Gertrud; Jørgensen, Per; Nordentoft, Merete

doi:10.1001/archpsyc.65.7.762

Cited by 417 publications

(454 citation statements)

References 36 publications

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“…For the trials with long term follow-up after the end of the intervention period, the results were more contradictory 1415 16 The largest randomised clinical trial of SEI treatment, the OPUS I trial,3 15 17 found that participants in the intervention group relapsed to the psychopathological and functional levels of the control participants three years after the end of the intervention 15. In a naturalistic study from Canada, researchers testing the effect of five years of SEI treatment found that they could sustain and further reduce the psychopathology and increase the functional level of the participants 18…”

Section: Introductionmentioning

confidence: 99%

Five years of specialised early intervention versus two years of specialised early intervention followed by three years of standard treatment for patients with a first episode psychosis: randomised, superiority, parallel group trial in Denmark (OPUS II)

Albert

Melau

Jensen

et al. 2017

BMJ

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Objective To compare the effects of five years of specialised early intervention (SEI) treatment for first episode schizophrenia spectrum disorder with the standard two years of SEI plus three years of treatment as usual.Design Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site.Setting Participants were recruited from six OPUS teams in Denmark between 2009 and 2012. OPUS teams provide SEI treatment to all patients diagnosed with a schizophrenia spectrum disorder in Denmark.Participants 400 participants (51% women) with a mean age of 25.6 (standard deviation 4.3) were randomised to five years of SEI (experimental intervention; n=197) or to two years of SEI plus three years of treatment as usual (control; n=203).Interventions OPUS treatment consists of three core elements—modified assertive community treatment, family involvement, and social skill training—with a patient-case manager ratio of no more than 12:1. For participants randomised to five years of OPUS treatment, the treatment was largely unchanged. Participants randomised to the control group were mostly referred to community health centres after two years of SEI treatment.Main outcomes Follow-up assessments were conducted five years after start of OPUS treatment. Primary outcome was negative symptoms measured on the scale for assessment of negative symptoms (avolition-apathy, anhedonia, alogia, and affective blunting). Secondary outcomes were remission of both negative and psychotic symptoms, psychotic symptoms, suicidal ideation, substance abuse, compliance with medical treatment, adherence with treatment, client satisfaction, days in hospital care, and labour market affiliation.Results Levels of negative symptoms did not differ between the intervention group and control group (1.72 v 1.81 points; estimated mean difference −0.10 (95% confidence interval 0.33 to 0.13), P=0.39). Participants receiving five years of OPUS treatment were more likely to remain in contact with specialised mental health services (90.4% v 55.6%, P<0.001), had higher client satisfaction (estimated mean difference 2.57 points (95% confidence interval 1.36 to 3.79), P<0.001), and had a stronger working alliance (estimated mean difference 5.56 points (95% confidence interval 2.30 to 8.82), P=0.001) than the control group.Conclusions This trial tests SEI treatment for up to five years for patients with first episode schizophrenia spectrum disorder; previous trials have found treatment effects for programmes lasting from one to three years. The prolonged SEI treatment had few effects, which could be due to the high level of treatment provided to control participants and the late start of specialised treatment.Trial registration Clinicaltrial.gov NCT00914238.

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Section: Introductionmentioning

confidence: 99%

Five years of specialised early intervention versus two years of specialised early intervention followed by three years of standard treatment for patients with a first episode psychosis: randomised, superiority, parallel group trial in Denmark (OPUS II)

Albert

Melau

Jensen

et al. 2017

BMJ

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“…The research, development and implementation of early intervention (EI) services in psychotic disorders over the past nearly two decades are now well established and the benefits well documented [3][4][5][6][7]. This has been achieved through a major philosophical shift in the conceptual framework of the disorder and changes in the form and content of services modified to meet the needs of younger and treatment naïve patients.…”

Section: Early Intervention In Psychosis and Youth Mental Health Servmentioning

confidence: 99%

From early intervention in psychosis to youth mental health reform: a review of the evolution and transformation of mental health services for young people

Malla

Iyer

McGorry

et al. 2015

Soc Psychiatry Psychiatr Epidemiol

159

163

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Abstract:Purpose: Developments in the field of early intervention in psychotic disorders have encouraged further examination of and interest in youth mental health incorporating all levels of severity of mental disorders. Methods:The authors have briefly reviewed the relevant current state of knowledge, challenges and the service and research response across four countries (Australia, Ireland, the U.K. and Canada) most active in this field.Results: Here we present information on response to principal challenges associated with improving youth mental services in each country. Australia has developed a model comprised of a distinct front line youth mental health service (Headspace) to be implemented across the country and initially stimulated by success in early intervention in psychosis;in Ireland, Headstrong has been driven primarily through advocacy and philanthropy resulting in front line services (Jigsaw) which are being implemented across different jurisdictions; in the UK a limited regional response has addressed mostly problems with transition from child-adolescent to adult mental health services; and in Canada a national multi-site research initiative involving transformation of youth mental health services has been launched with public and philanthropic funding, with the expectation that results of this study will inform implementation of a transformed model of service across the country including indigenous peoples. Conclusions:There is evidence that several countries are now engaged in transformation of youth mental health services and in evaluation of these initiatives.

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“…In particular, an increasing body of evidence suggests that treatment of patients with schizophrenia may be more effective when initiated and maintained early in the course of the disease 3, 4, 5, 6. Evidence suggests that treatment response tends to diminish with each successive psychotic episode and that most functional deterioration occurs within 5 years of onset 1, 7.…”

Section: Introductionmentioning

confidence: 99%

Treatment effect with paliperidone palmitate compared with oral antipsychotics in patients with recent‐onset versus more chronic schizophrenia and a history of criminal justice system involvement

Alphs

Bossie

Mao

et al. 2015

Early Intervention Psych

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AimLong‐acting injectable antipsychotics (APs) are not well studied in recent‐onset schizophrenia. This exploratory analysis of a study designed to reflect real‐world schizophrenia, as defined by patients, interventions and outcomes, compared relative treatment effect between once‐monthly paliperidone palmitate (PP) and daily oral APs in patients with recent‐onset or chronic illnessMethodsThis randomized, open‐label, event monitoring board–blinded study compared treatment response in subjects with schizophrenia and a history of criminal justice system involvement following treatment with PP or oral APs for 15 months (ClinicalTrials.gov identifier, NCT01157351). Event‐free probabilities were estimated using Kaplan–Meier method; hazard ratios (HRs) were estimated using Cox proportional hazard models. This subgroup analysis analysed data by disease duration (≤5 (recent‐onset) or >5 years (chronic illness) since first psychiatric diagnosis).ResultsSeventy‐seven subjects met the criteria for recent‐onset illness; 365 for chronic illness. HRs (95% CI) for treatment failure for oral APs versus PP were 1.73 (0.87–3.45; P = 0.121) for recent‐onset and 1.37 (1.02–1.85; P = 0.039) for chronic illness. Most common adverse events for PP versus oral APs were injection site pain (recent‐onset, 26% vs. 0%; chronic, 17% vs. 0%), increased weight (14% vs. 6%; 12% vs. 6%), akathisia (14% vs. 9%; 10% vs. 7%), insomnia (12% vs. 17%; 18% vs. 10%) and anxiety (12% vs. 6%; 10% vs. 8%).ConclusionsAlthough neither pre‐planned nor adequately powered, the estimated HRs suggest that the relative advantage of PP over oral APs for reducing the risk for treatment failure may be greater in patients with recent‐onset schizophrenia than in those with more chronic illness.

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Five-Year Follow-up of a Randomized Multicenter Trial of Intensive Early Intervention vs Standard Treatment for Patients With a First Episode of Psychotic Illness

Cited by 417 publications

References 36 publications

Five years of specialised early intervention versus two years of specialised early intervention followed by three years of standard treatment for patients with a first episode psychosis: randomised, superiority, parallel group trial in Denmark (OPUS II)

Five years of specialised early intervention versus two years of specialised early intervention followed by three years of standard treatment for patients with a first episode psychosis: randomised, superiority, parallel group trial in Denmark (OPUS II)

From early intervention in psychosis to youth mental health reform: a review of the evolution and transformation of mental health services for young people

Treatment effect with paliperidone palmitate compared with oral antipsychotics in patients with recent‐onset versus more chronic schizophrenia and a history of criminal justice system involvement

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