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| Name | Class |
|---|---|
| Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital | OTHER |
| Region Capital Denmark | OTHER |
| Medical Research Council | OTHER_GOV |
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In a randomized clinical trial, the researchers want to investigate if the positive short-term outcomes (first 1-2 years), achieved with specialized assertive intervention programme (OPUS), can be maintained for five years if the specialized treatment is sustained over the first five years in comparison to only two years of specialized treatment followed by three years of standard treatment.
The Danish OPUS I trial succeeded in randomizing 547 patients with first-episode psychosis to a two-year specialized intensive treatment program (OPUS) or standard treatment. The results clearly favored OPUS treatment, and psychotic and negative symptoms, substance abuse, adherence to treatment, use of anti-psychotic medication, user satisfaction, and use of bed days were better in OPUS compared to standard treatment. However, the five-year follow-up, three years after patients from OPUS were transferred to standard treatment, showed that the positive clinical effects were not sustained, when the intensive treatment was terminated, except from OPUS-patients being less likely to stay in institutions than patients who received standard care.
Objective: The aim in OPUS II trial is to compare the effect of five-years versus two-years specialized assertive intervention program (OPUS-treatment) for first episode psychosis on clinical symptoms, substance abuse, institutionalization, and labor market affiliation.
Hypothesis: It is possible to maintain the positive results of the intensive two-year intervention in another three years for those who keep receiving the specialized assertive intervention program.
Design: Open label randomized clinical trial. Setting: Psychiatric Center Bispebjerg and Center for Psychiatric Research Aarhus, Denmark.Participants: 400 patients with first episode of schizophrenia spectrum disorder received treatment in one of the six OPUS - teams for 1½ years.
Intervention: Another 3½ years OPUS-treatment versus ½ year OPUS-treatment and thereafter referral to standard treatment. The extended OPUS treatment consist modified assertive case management, rational pharmacotherapy, family psycho-educational intervention, group interventions to aid with recovery, social skills training, cognitive behavior therapy when indicated, and crisis intervention. OPUS-treatment is tailored to meet the individual patient's needs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 year | Experimental | 5 years OPUS treatment |
|
| 2 years of OPUS treatment | Active Comparator | 2 years OPUS treatment and 3 years of treatment as usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 years OPUS treatment | Behavioral | 2 years OPUS and transfer to standard treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Psychotic symptoms | 3 years | |
| Simultaneous remission of both psychotic and negative symptoms. | 3 years | |
| Substance abuse. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merete Nordentoft, Professor | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Center Bispebjerg | Copenhagen | 2400 | Denmark | |||
| Psychiatric Centre Bispebjerg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33135812 | Derived | Puntis S, Minichino A, De Crescenzo F, Cipriani A, Lennox B, Harrison R. Specialised early intervention teams (extended time) for recent-onset psychosis. Cochrane Database Syst Rev. 2020 Nov 2;11(11):CD013287. doi: 10.1002/14651858.CD013287.pub2. | |
| 30058511 | Derived | Albert N, Randers L, Allott K, Jensen HD, Melau M, Hjorthoj C, Nordentoft M. Cognitive functioning following discontinuation of antipsychotic medication. A naturalistic sub-group analysis from the OPUS II trial. Psychol Med. 2019 May;49(7):1138-1147. doi: 10.1017/S0033291718001836. Epub 2018 Jul 30. |
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| ID | Term |
|---|---|
| D012569 | Schizotypal Personality Disorder |
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| Aarhus University Hospital |
| OTHER |
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| OPUS 5 years | Behavioral |
|
| 3 years |
| Suicidal behaviour. | 3 years |
| Use of bed days. | 3 years |
| Independent living. | 3 Years |
| Labour market affiliation. | 3 years |
| User satisfaction. | 3 years |
| Adherence to treatment. | 3 years |
| Compliance with medication | 3 years |
| Copenhagen |
| 2400 |
| Denmark |
| 28082379 | Derived | Albert N, Melau M, Jensen H, Emborg C, Jepsen JR, Fagerlund B, Gluud C, Mors O, Hjorthoj C, Nordentoft M. 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). BMJ. 2017 Jan 12;356:i6681. doi: 10.1136/bmj.i6681. |
| 25650684 | Derived | Melau M, Harder S, Jeppesen P, Hjorthoj C, Jepsen JR, Thorup A, Nordentoft M. The association between working alliance and clinical and functional outcome in a cohort of 400 patients with first-episode psychosis: a cross-sectional study. J Clin Psychiatry. 2015 Jan;76(1):e83-90. doi: 10.4088/JCP.13m08814. |
| 21392377 | Derived | Melau M, Jeppesen P, Thorup A, Bertelsen M, Petersen L, Gluud C, Krarup G, Nordentoft M. The effect of five years versus two years of specialised assertive intervention for first episode psychosis - OPUS II: study protocol for a randomized controlled trial. Trials. 2011 Mar 10;12:72. doi: 10.1186/1745-6215-12-72. |