NCT00157313

Brief Summary

The purpose of the study was to evaluate the effects of integrated treatment for patients with a first episode of psychotic illness. We conducted a randomised clinical trial in Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark. We included 547 patients with first episode of schizophrenia spectrum disorder, who has not received antipsychotic medication for more than 12 weeks. Patients were randomised to integrated treatment or standard treatment. The integrated treatment lasted for two years and consisted of assertive community treatment with programmes for family involvement and social skills training. Standard treatment offered contact with a community mental health centre. We wanted to study the effect on psychotic (hallucinations and delusions)and negative (lack of initiative, apati, blunted affect) symptoms (each scored from 0 to a maximum of 5) at one and two years' follow-up. We found that integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent at one year and two year follow-ups. We will study further outcome measures such as social network, quality of life, depression and suicidal behaviour.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 1998

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 1998

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
17.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 28, 2016

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

January 27, 2016

Conditions

Psychotic DisordersSchizophreniform DisordersSchizoaffective DisorderPsychosis, Brief ReactiveSchizophrenia, Borderline

Keywords

SchizophreniaFirst episode psychosisPsychosocial intervention

Outcome Measures

Primary Outcomes (2)

  • Psychotic symptoms at one and two year follow-up

  • Negative symptoms at one and two year follow-up

Secondary Outcomes (5)

  • Adherence at one and two year follow-up

  • Depression at one and two year follow-up

  • Suicidal behaviour at one and two year follow-up

  • Use satisfaction at one and two year follow-up

  • Quality of life at one and two year follow-up

Interventions

Integrated treatment, family involvementBEHAVIORAL
Social skills trainingBEHAVIORAL

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • F2 diagnosis in ICD 10
  • Address in Copenhagen, Frederiksberg or Aarhus
  • Antipsychotic medication not exceeding 12 weeks
  • Informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital, department of psychiatry

Copenhagen, 2400, Denmark

Location

Related Publications (11)

  • Jorgensen P, Nordentoft M, Abel MB, Gouliaev G, Jeppesen P, Kassow P. Early detection and assertive community treatment of young psychotics: the Opus Study Rationale and design of the trial. Soc Psychiatry Psychiatr Epidemiol. 2000 Jul;35(7):283-7. doi: 10.1007/s001270050240.

    PMID: 11016522BACKGROUND

  • Nordentoft M, Jeppesen P, Abel M, Kassow P, Petersen L, Thorup A, Krarup G, Hemmingsen R, Jorgensen P. OPUS study: suicidal behaviour, suicidal ideation and hopelessness among patients with first-episode psychosis. One-year follow-up of a randomised controlled trial. Br J Psychiatry Suppl. 2002 Sep;43:s98-106. doi: 10.1192/bjp.181.43.s98.

    PMID: 12271808RESULT

  • Petersen L, Jeppesen P, Thorup A, Abel MB, Ohlenschlaeger J, Christensen TO, Krarup G, Jorgensen P, Nordentoft M. A randomised multicentre trial of integrated versus standard treatment for patients with a first episode of psychotic illness. BMJ. 2005 Sep 17;331(7517):602. doi: 10.1136/bmj.38565.415000.E01. Epub 2005 Sep 2.

    PMID: 16141449RESULT

  • Thorup A, Petersen L, Jeppesen P, Ohlenschlaeger J, Christensen T, Krarup G, Jorgensen P, Nordentoft M. Integrated treatment ameliorates negative symptoms in first episode psychosis--results from the Danish OPUS trial. Schizophr Res. 2005 Nov 1;79(1):95-105. doi: 10.1016/j.schres.2004.12.020.

    PMID: 16122909RESULT

  • Petersen L, Nordentoft M, Jeppesen P, Ohlenschaeger J, Thorup A, Christensen TO, Krarup G, Dahlstrom J, Haastrup B, Jorgensen P. Improving 1-year outcome in first-episode psychosis: OPUS trial. Br J Psychiatry Suppl. 2005 Aug;48:s98-103. doi: 10.1192/bjp.187.48.s98.

    PMID: 16055817RESULT

  • Jeppesen P, Petersen L, Thorup A, Abel MB, Oehlenschlaeger J, Christensen TO, Krarup G, Hemmingsen R, Jorgensen P, Nordentoft M. Integrated treatment of first-episode psychosis: effect of treatment on family burden: OPUS trial. Br J Psychiatry Suppl. 2005 Aug;48:s85-90. doi: 10.1192/bjp.187.48.s85.

    PMID: 16055815RESULT

  • Rosenbaum B, Valbak K, Harder S, Knudsen P, Koster A, Lajer M, Lindhardt A, Winther G, Petersen L, Jorgensen P, Nordentoft M, Andreasen AH. The Danish National Schizophrenia Project: prospective, comparative longitudinal treatment study of first-episode psychosis. Br J Psychiatry. 2005 May;186:394-9. doi: 10.1192/bjp.186.5.394.

    PMID: 15863743RESULT

  • Starzer MSK, Hansen HG, Hjorthoj C, Speyer H, Albert N, Nordentoft M. Predictors of Mortality Following a Schizophrenia Spectrum Diagnosis: Evidence From the 20-Year Follow-up of the OPUS Randomized Controlled Trial. Schizophr Bull. 2023 Sep 7;49(5):1256-1268. doi: 10.1093/schbul/sbad111.

    PMID: 37527479DERIVED

  • Hansen HG, Starzer M, Nilsson SF, Hjorthoj C, Albert N, Nordentoft M. Clinical Recovery and Long-Term Association of Specialized Early Intervention Services vs Treatment as Usual Among Individuals With First-Episode Schizophrenia Spectrum Disorder: 20-Year Follow-up of the OPUS Trial. JAMA Psychiatry. 2023 Apr 1;80(4):371-379. doi: 10.1001/jamapsychiatry.2022.5164.

    PMID: 36811902DERIVED

  • Madsen T, Karstoft KI, Secher RG, Austin SF, Nordentoft M. Trajectories of suicidal ideation in patients with first-episode psychosis: secondary analysis of data from the OPUS trial. Lancet Psychiatry. 2016 May;3(5):443-50. doi: 10.1016/S2215-0366(15)00518-0. Epub 2016 Mar 3.

    PMID: 26948484DERIVED

  • Jeppesen P, Petersen L, Thorup A, Abel MB, Ohlenschlaeger J, Christensen TO, Krarup G, Jorgensen P, Nordentoft M. The association between pre-morbid adjustment, duration of untreated psychosis and outcome in first-episode psychosis. Psychol Med. 2008 Aug;38(8):1157-66. doi: 10.1017/S0033291708003449. Epub 2008 Apr 30.

    PMID: 18447961DERIVED

MeSH Terms

Conditions

Psychotic DisordersSchizotypal Personality DisorderSchizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPersonality Disorders

Study Officials

  • Merete Nordentoft, Ph.D.

    Bispebjerg Hospital, department of psychiatry, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

January 1, 1998

Study Completion

December 1, 2022

Last Updated

January 28, 2016

Record last verified: 2005-09

Locations

DK(1)