Extended Specialized Assertive Intervention for First Episode Psychosis (OPUSII)

This study has been completed.

Sponsor:

Collaborators:

Mental Health Centre Copenhagen

Region Capital 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: October 24, 2016

Last verified: October 2016

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 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:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Mental Disorders Psychotic Disorders

U.S. FDA Resources

Further study details as provided by Merete Nordentoft, Professor, DMSc., Mental Health Centre Copenhagen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

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

Region Capital 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):

Albert N, Melau M, Jensen H, Emborg C, Jepsen JR, Fagerlund B, Gluud C, Mors O, Hjorthøj C, Nordentoft M. Five years of specialised early intervention versus two years of specialised early intervention followed by three years of standard treatment for patients with a first episode psychosis: randomised, superiority, parallel group trial in Denmark (OPUS II). BMJ. 2017 Jan 12;356:i6681. doi: 10.1136/bmj.i6681.

Melau M, Harder S, Jeppesen P, Hjorthøj C, Jepsen JR, Thorup A, Nordentoft M. The association between working alliance and clinical and functional outcome in a cohort of 400 patients with first-episode psychosis: a cross-sectional study. J Clin Psychiatry. 2015 Jan;76(1):e83-90. doi: 10.4088/JCP.13m08814.

Melau M, Jeppesen P, Thorup A, Bertelsen M, Petersen L, Gluud C, Krarup G, Nordentoft M. The effect of five years versus two years of specialised assertive intervention for first episode psychosis - OPUS II: study protocol for a randomized controlled trial. Trials. 2011 Mar 10;12:72. doi: 10.1186/1745-6215-12-72.


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 May 25, 2017

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