Extended Specialized Assertive Intervention for First Episode Psychosis
OPUSII
A Randomized Clinical Trial of the Effect of Five-years Versus Two-years Specialized Assertive Intervention for First Episode Psychosis - the OPUS II Trial
1 other identifier
interventional
400
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2009
CompletedFirst Posted
Study publicly available on registry
June 4, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 25, 2016
October 1, 2016
5.9 years
May 28, 2009
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Negative symptoms, measured with Schedule for Assessment of Negative Symptoms in Schizophrenia, (SANS)
3 years
Secondary Outcomes (10)
Psychotic symptoms
3 years
Simultaneous remission of both psychotic and negative symptoms.
3 years
Substance abuse.
3 years
Suicidal behaviour.
3 years
Use of bed days.
3 years
- +5 more secondary outcomes
Study Arms (2)
5 year
EXPERIMENTAL5 years OPUS treatment
2 years of OPUS treatment
ACTIVE COMPARATOR2 years OPUS treatment and 3 years of treatment as usual
Interventions
2 years OPUS and transfer to standard treatment.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Copenhagenlead
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospitalcollaborator
- Region Capital Denmarkcollaborator
- Medical Research Councilcollaborator
- Aarhus University Hospitalcollaborator
Study Sites (2)
Psychiatric Center Bispebjerg
Copenhagen, 2400, Denmark
Psychiatric Centre Bispebjerg
Copenhagen, 2400, Denmark
Related Publications (5)
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.
PMID: 33135812DERIVEDAlbert 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.
PMID: 30058511DERIVEDAlbert 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.
PMID: 28082379DERIVEDMelau 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.
PMID: 25650684DERIVEDMelau 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.
PMID: 21392377DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Merete Nordentoft, Professor
University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 28, 2009
First Posted
June 4, 2009
Study Start
July 1, 2009
Primary Completion
June 1, 2015
Study Completion
October 1, 2016
Last Updated
October 25, 2016
Record last verified: 2016-10