Clinical trial NCT00914238: Extended Specialized Assertive Intervention for First Episode Psychosis
Official title: A Randomized Clinical Trial of the Effect of Five-years Versus Two-years Specialized Assertive Intervention for First Episode Psychosis - the OPUS II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: First Episode Psychosis of Schizophrenia and Schizotypal Disorder
Psychotic Disorders
Schizophrenia
Schizoaffective Disorder
Keywords: Randomized clinical trial
first episode psychosis of schizophrenia and schizotypal disorder
rehabilitation
psychosocial
health service research
schizotypal Disorder
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Mental Health Services in the Capital Region, Denmark
name: Region Capital Denmark
name: Medical Research Council
name: Aarhus University Hospital
First posted: 2009-06-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients aged 18 - 37 years
* first episode psychosis in schizophrenia spectrum
* treated for 1½ year in the five OPUS teams in the Capital Region and the OPUS teams in Region Midt
* patients who will give signed informed consent to participate in the trial

Exclusion Criteria:

* patients who are not treated in one of the OPUS team in the Capital Region and Region Midt
* patients who don't give signed informed consent to participate in the study

Primary outcomes:
measure: Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS)
timeFrame: 3 years
Secondary outcomes:
measure: Psychotic symptoms
timeFrame: 3 years
measure: Simultaneous remission of both psychotic and negative symptoms.
timeFrame: 3 years
measure: Substance abuse.
timeFrame: 3 years
measure: Suicidal behaviour.
timeFrame: 3 years
measure: Use of bed days.
timeFrame: 3 years
measure: Independent living.
timeFrame: 3 Years
measure: Labour market affiliation.
timeFrame: 3 years
measure: User satisfaction.
timeFrame: 3 years
measure: Adherence to treatment.
timeFrame: 3 years
measure: Compliance with medication
timeFrame: 3 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Psychiatric Center Bispebjerg
city: Copenhagen
country: Denmark
facility: Psychiatric Centre Bispebjerg
Study officials:
affiliation: University of Copenhagen
name: Merete Nordentoft, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.