- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00157313
Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objectives: To evaluate the effects of integrated treatment for patients with a first episode of psychotic illness.
Design: Randomised clinical trial. Setting: Copenhagen Hospital Corporation and Psychiatric Hospital Aarhus, Denmark Participants: 547 patients with first episode of schizophrenia spectrum disorder.
Interventions: Integrated treatment and 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.
Main outcome measures: Psychotic and negative symptoms (each scored from 0 to a maximum of 5) at one and two years' follow-up.
Results: At one year's follow-up, psychotic symptoms changed favourably to a mean of 1.09 (standard deviation 1.27) with an estimated mean difference between groups of -0.31 (95% confidence interval -0.55 to -0.07, P=0.02) in favour of integrated treatment. Negative symptoms changed favourably with a estimated difference between groups of -0.36 (-0.54 to -0.17, P<0.001) in favour of integrated treatment. At two years' follow-up the estimated mean difference between groups in psychotic symptoms was -0.32 (-0.58 to -0.06, P=0.02) and in negative symptoms was -0.45 (-0.67 to -0.22, P<0.001), both in favour of integrated treatment. Patients who received integrated treatment had significantly less comorbid substance misuse, better adherence to treatment, and more satisfaction with treatment.
Conclusion: Integrated treatment improved clinical outcome and adherence to treatment. The improvement in clinical outcome was consistent at one year and two year follow-ups.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2400
- Bispebjerg Hospital, department of psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18-45 years of age
- F2 diagnosis in ICD 10
- Address in Copenhagen, Frederiksberg or Aarhus
- Antipsychotic medication not exceeding 12 weeks
- Informed consent
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Psychotic symptoms at one and two year follow-up
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Negative symptoms at one and two year follow-up
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Secondary Outcome Measures
Outcome Measure |
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Adherence at one and two year follow-up
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Depression at one and two year follow-up
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Suicidal behaviour at one and two year follow-up
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Use satisfaction at one and two year follow-up
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Quality of life at one and two year follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Merete Nordentoft, Ph.D., Bispebjerg Hospital, department of psychiatry, University of Copenhagen
Publications and helpful links
General Publications
- 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.
- 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.
- 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. Erratum In: BMJ. 2005 Nov 5;331(7524):1065.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPUS trial
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