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Extended Specialized Assertive Intervention for First Episode Psychosis (OPUSII)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Mental Health Centre Copenhagen
Capital Region of Denmark
Medical Research Council
Aarhus University Hospital
Information provided by (Responsible Party):
Merete Nordentoft, Professor, DMSc., Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier:
NCT00914238
First received: May 28, 2009
Last updated: January 24, 2014
Last verified: January 2014
History of Changes
  Purpose
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 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
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Psychotic symptoms [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Simultaneous remission of both psychotic and negative symptoms. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Substance abuse. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Suicidal behaviour. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Use of bed days. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Independent living. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
  • Labour market affiliation. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • User satisfaction. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Adherence to treatment. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Compliance with medication [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 400
Study Start Date: July 2009
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: May 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)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914238

Locations
Denmark
Psychiatric Center Bispebjerg
Copenhagen, Denmark, 2400
Psychiatric Centre Bispebjerg
Copenhagen, Denmark, 2400
Sponsors and Collaborators
University of Copenhagen
Mental Health Centre Copenhagen
Capital Region of Denmark
Medical Research Council
Aarhus University Hospital
Investigators
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: January 24, 2014
Health Authority: Denmark: Ministry of Health
Denmark: Danish Dataprotection Agency

Keywords provided by University of 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 September 26, 2016