Extended Specialized Assertive Intervention for First Episode Psychosis (OPUSII)

October 24, 2016 updated by: Merete Nordentoft, Professor, DMSc., University of Copenhagen

A Randomized Clinical Trial of the Effect of Five-years Versus Two-years Specialized Assertive Intervention for First Episode Psychosis - the OPUS II Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Psychiatric Center Bispebjerg
      • Copenhagen, Denmark, 2400
        • Psychiatric Centre Bispebjerg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Psychotic symptoms
Time Frame: 3 years
3 years
Simultaneous remission of both psychotic and negative symptoms.
Time Frame: 3 years
3 years
Substance abuse.
Time Frame: 3 years
3 years
Suicidal behaviour.
Time Frame: 3 years
3 years
Use of bed days.
Time Frame: 3 years
3 years
Independent living.
Time Frame: 3 Years
3 Years
Labour market affiliation.
Time Frame: 3 years
3 years
User satisfaction.
Time Frame: 3 years
3 years
Adherence to treatment.
Time Frame: 3 years
3 years
Compliance with medication
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Aarhus University Hospital
Medical Research Council
Region Capital Denmark
Mental Health Centre Copenhagen

Investigators

  • Principal Investigator: Merete Nordentoft, Professor, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

June 3, 2009

First Posted (ESTIMATE)

June 4, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Danish OPUS II trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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