This trial is active, not recruiting.

Conditions first episode psychosis of schizophrenia and schizotypal disorder, psychotic disorders, schizophrenia, schizoaffective disorder
Treatments 2 years opus treatment, opus 5 years
Sponsor University of Copenhagen
Collaborator Mental Health Centre Copenhagen
Start date July 2009
End date May 2015
Trial size 400 participants
Trial identifier NCT00914238, Danish OPUS II trial


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
5 years OPUS treatment
opus 5 years
(Active Comparator)
2 years OPUS treatment and 3 years of treatment as usual
2 years opus treatment
2 years OPUS and transfer to standard treatment.

Primary Outcomes

Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS)
time frame: 3 years

Secondary Outcomes

Psychotic symptoms
time frame: 3 years
Simultaneous remission of both psychotic and negative symptoms.
time frame: 3 years
Substance abuse.
time frame: 3 years
Suicidal behaviour.
time frame: 3 years
Use of bed days.
time frame: 3 years
Independent living.
time frame: 3 Years
Labour market affiliation.
time frame: 3 years
User satisfaction.
time frame: 3 years
Adherence to treatment.
time frame: 3 years
Compliance with medication
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 37 years old.

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

Additional Information

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
Principal investigator Merete Nordentoft, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University of Copenhagen.