First Episode Psychosis of Schizophrenia and Schizotypal DisorderOPUSIINCT00914238
Extended Specialized Assertive Intervention for First Episode Psychosis
A study testing 2 years OPUS treatment and OPUS 5 years in people with First Episode Psychosis of Schizophrenia and Schizotypal Disorder and Psychotic Disorders, run by University of Copenhagen at 2 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 37 years
- Conditions the study is for
- First Episode Psychosis of Schizophrenia and Schizotypal Disorder, Psychotic Disorders, Schizophrenia
- What is being tested?
- 2 years OPUS treatment and OPUS 5 years
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesDenmark
- Study dates
- Jul 2009to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Psychiatric Center Bispebjerg
Copenhagen, 2400
Psychiatric Centre Bispebjerg
Copenhagen, 2400
About this study
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
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.
Read the 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.
- Conditions
- First Episode Psychosis of Schizophrenia and Schizotypal Disorder, Psychotic Disorders, Schizophrenia, Schizoaffective Disorder
- Being tested
- 2 years OPUS treatment, OPUS 5 years
- Keywords
- Randomized clinical trial, first episode psychosis of schizophrenia and schizotypal disorder, rehabilitation, psychosocial, health service research, schizotypal Disorder
- Medical subject headings
- Schizotypal Personality Disorder, Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 years OPUS treatmentBehavioural
2 years OPUS and transfer to standard treatment.
OPUS 5 yearsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 5 year | Experimental | 5 years OPUS treatment Receives: Behavioral: OPUS 5 years |
| 2 years of OPUS treatment | Active comparator | 2 years OPUS treatment and 3 years of treatment as usual Receives: Behavioral: 2 years OPUS treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS)
Measured: 3 years
Secondary outcomes (10)
Psychotic symptoms
Measured: 3 years
Simultaneous remission of both psychotic and negative symptoms.
Measured: 3 years
Substance abuse.
Measured: 3 years
Suicidal behaviour.
Measured: 3 years
Use of bed days.
Measured: 3 years
Independent living.
Measured: 3 Years
Labour market affiliation.
Measured: 3 years
User satisfaction.
Measured: 3 years
Adherence to treatment.
Measured: 3 years
Compliance with medication
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for First Episode Psychosis of Schizophrenia and Schizotypal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital, Region Capital Denmark, Medical Research Council, Aarhus University Hospital
- Responsible party
- Principal investigator, Merete Nordentoft, Professor, DMSc., Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Merete Nordentoft, Professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914238
- Sponsor's protocol ID
- Danish OPUS II trial
- Acronym
- OPUSII
- Status last verified
- Oct 2016
- First submitted
- 28 May 2009
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Puntis S, Minichino A, De Crescenzo F, Cipriani A, Lennox B, Harrison R. Specialised early intervention teams (extended time) for recent-onset psychosis. Cochrane Database Syst Rev. 2020 Nov 2;11(11):CD013287. doi: 10.1002/14651858.CD013287.pub2.
PubMed 33135812Albert N, Randers L, Allott K, Jensen HD, Melau M, Hjorthoj C, Nordentoft M. Cognitive functioning following discontinuation of antipsychotic medication. A naturalistic sub-group analysis from the OPUS II trial. Psychol Med. 2019 May;49(7):1138-1147. doi: 10.1017/S0033291718001836. Epub 2018 Jul 30.
PubMed 30058511Albert N, Melau M, Jensen H, Emborg C, Jepsen JR, Fagerlund B, Gluud C, Mors O, Hjorthoj 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.
PubMed 28082379Melau M, Harder S, Jeppesen P, Hjorthoj 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.
PubMed 25650684Melau 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.
PubMed 21392377
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00914238
- Acronym / sponsor ID
- OPUSII / Danish OPUS II trial
- Conditions
- First Episode Psychosis of Schizophrenia and Schizotypal Disorder, Psychotic Disorders, Schizophrenia, Schizoaffective Disorder
- Keywords
- Randomized clinical trial, first episode psychosis of schizophrenia and schizotypal disorder, rehabilitation, psychosocial, health service research, schizotypal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital, Region Capital Denmark, Medical Research Council, Aarhus University Hospital
- Study start
- Jul 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 year | Experimental | Behavioral: OPUS 5 years5 years OPUS treatment |
| 2 years of OPUS treatment | Active comparator | Behavioral: 2 years OPUS treatment2 years OPUS treatment and 3 years of treatment as usual |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 years OPUS treatment2 years OPUS and transfer to standard treatment. | Behavioural | 2 years of OPUS treatment |
| OPUS 5 years | Behavioural | 5 year |
Primary outcome
Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS)
Time frame: 3 years
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Derived from this study: PubMed 33135812Puntis S, Minichino A, De Crescenzo F, Cipriani A, Lennox B, Harrison R. Specialised early intervention teams (extended time) for recent-onset psychosis. Cochrane Database Syst Rev. 2020 Nov 2;11(11):CD013287. doi: 10.1002/14651858.CD013287.pub2.
- Derived from this study: PubMed 30058511Albert N, Randers L, Allott K, Jensen HD, Melau M, Hjorthoj C, Nordentoft M. Cognitive functioning following discontinuation of antipsychotic medication. A naturalistic sub-group analysis from the OPUS II trial. Psychol Med. 2019 May;49(7):1138-1147. doi: 10.1017/S0033291718001836. Epub 2018 Jul 30.
- Derived from this study: PubMed 28082379Albert N, Melau M, Jensen H, Emborg C, Jepsen JR, Fagerlund B, Gluud C, Mors O, Hjorthoj 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.
- Derived from this study: PubMed 25650684Melau M, Harder S, Jeppesen P, Hjorthoj 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.
- Derived from this study: PubMed 21392377Melau 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Nordentoft, Professor principal investigator
University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 years OPUS treatment and OPUS 5 years in people with First Episode Psychosis of Schizophrenia and Schizotypal Disorder and Psychotic Disorders, run by University of Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00914238, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016; AzTrials last refreshed its copy on 26 Oct 2026.