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Extended Specialized Assertive Intervention for First Episode Psychosis (OPUSII)
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Purpose
| Condition | Intervention |
|---|---|
| First Episode Psychosis of Schizophrenia and Schizotypal Disorder Psychotic Disorders Schizophrenia Schizoaffective Disorder | Behavioral: 2 years OPUS treatment Behavioral: OPUS 5 years |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 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 ]
| Enrollment: | 400 |
| Study Start Date: | July 2009 |
| Study Completion Date: | October 2016 |
| Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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| Ages Eligible for Study: | 18 Years to 37 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00914238
| Denmark | |
| Psychiatric Center Bispebjerg | |
| Copenhagen, Denmark, 2400 | |
| Psychiatric Centre Bispebjerg | |
| Copenhagen, Denmark, 2400 | |
| Principal Investigator: | Merete Nordentoft, Professor | University of Copenhagen |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merete Nordentoft, Professor, DMSc., Professor, Mental Health Centre Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00914238 History of Changes |
| Other Study ID Numbers: |
Danish OPUS II trial |
| Study First Received: | May 28, 2009 |
| Last Updated: | October 24, 2016 |
Keywords provided by Merete Nordentoft, Professor, DMSc., Mental Health Centre Copenhagen:
|
Randomized clinical trial first episode psychosis of schizophrenia and schizotypal disorder rehabilitation |
psychosocial health service research schizotypal Disorder |
Additional relevant MeSH terms:
|
Disease Schizophrenia Psychotic Disorders Mental Disorders |
Schizotypal Personality Disorder Pathologic Processes Schizophrenia Spectrum and Other Psychotic Disorders Personality Disorders |
ClinicalTrials.gov processed this record on July 19, 2017