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NCT Number: NCT00914238

Extended Specialized Assertive Intervention for First Episode Psychosis

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.

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Key information

Conditions

First Episode Psychosis of Schizophrenia and Schizotypal Disorder Mental Disorders Personality Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Schizotypal Personality Disorder

Age range

18 year–37 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatric Center Bispebjerg, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2 years OPUS treatment

Behavioral

2 years OPUS and transfer to standard treatment.

OPUS 5 years

Behavioral

Primary outcomes

  1. Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS)

    Time frame: 3 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Aarhus University Hospital
  • Medical Research Council
  • Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
  • Region Capital Denmark

Registry information

Official study 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

Acronym: OPUSII

Important dates

Study start
2009
Primary completion
2015
Study completion
2016
First posted
Jun 4, 2009
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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