Extended Specialized Assertive Intervention for First Episode Psychosis (OPUSII)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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	Phase
First Episode Psychosis of Schizophrenia and Schizotypal Disorder; Psychotic Disorders; Schizophrenia; Schizoaffective Disorder	Behavioral: 2 years OPUS treatment; Behavioral: OPUS 5 years	Not Applicable

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Actual Primary Completion Date :	June 2015
Actual Study Completion Date :	October 2016

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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. Erratum in: BMJ. 2017 Feb 24;356:j1015.

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
First Posted:	June 4, 2009
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; 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