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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
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
First Episode Psychosis of Schizophrenia and Schizotypal Disorder Psychotic Disorders Schizophrenia Schizoaffective Disorder Behavioral: 2 years OPUS treatment Behavioral: OPUS 5 years

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2009
Primary Completion Date : June 2015
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Psychotic symptoms [ Time Frame: 3 years ]
  2. Simultaneous remission of both psychotic and negative symptoms. [ Time Frame: 3 years ]
  3. Substance abuse. [ Time Frame: 3 years ]
  4. Suicidal behaviour. [ Time Frame: 3 years ]
  5. Use of bed days. [ Time Frame: 3 years ]
  6. Independent living. [ Time Frame: 3 Years ]
  7. Labour market affiliation. [ Time Frame: 3 years ]
  8. User satisfaction. [ Time Frame: 3 years ]
  9. Adherence to treatment. [ Time Frame: 3 years ]
  10. Compliance with medication [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
University of Copenhagen
Mental Health Centre Copenhagen
Region Capital Denmark
Medical Research Council
Aarhus University Hospital
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
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016

Keywords provided by Merete Nordentoft, Professor, DMSc., Mental Health Centre Copenhagen:
Randomized clinical trial
first episode psychosis of schizophrenia and schizotypal disorder
health service research
schizotypal Disorder

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizotypal Personality Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Personality Disorders