Extended Specialized Assertive Intervention for First Episode Psychosis (OPUSII)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|