Extended Specialized Assertive Intervention for First Episode Psychosis (OPUSII)
|ClinicalTrials.gov Identifier: NCT00914238|
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : October 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|First Episode Psychosis of Schizophrenia and Schizotypal Disorder Psychotic Disorders Schizophrenia Schizoaffective Disorder||Behavioral: 2 years OPUS treatment Behavioral: OPUS 5 years||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||July 2009|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||October 2016|
Experimental: 5 year
5 years OPUS treatment
Behavioral: OPUS 5 years
Active Comparator: 2 years of OPUS treatment
2 years OPUS treatment and 3 years of treatment as usual
Behavioral: 2 years OPUS treatment
2 years OPUS and transfer to standard treatment.
- Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) [ Time Frame: 3 years ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914238
|Psychiatric Center Bispebjerg|
|Copenhagen, Denmark, 2400|
|Psychiatric Centre Bispebjerg|
|Copenhagen, Denmark, 2400|
|Principal Investigator:||Merete Nordentoft, Professor||University of Copenhagen|