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Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis

Primary Purpose

Psychotic Disorders, Schizophreniform Disorders, Schizoaffective Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Integrated treatment, family involvement
Social skills training
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring Schizophrenia, First episode psychosis, Psychosocial intervention

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • Bispebjerg Hospital, department of psychiatry

Outcomes

Primary Outcome Measures

Psychotic symptoms at one and two year follow-up
Negative symptoms at one and two year follow-up

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2005
Last Updated
January 27, 2016
Sponsor
Bispebjerg Hospital
Collaborators
Ministry of the Interior and Health, Denmark, Ministry of Social Affairs, Denmark, University of Copenhagen, Copenhagen Hospital Corporation, Medical Research Council, Wørzners Foundation.
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1. Study Identification

Unique Protocol Identification Number
NCT00157313
Brief Title
Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
Official Title
Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Bispebjerg Hospital
Collaborators
Ministry of the Interior and Health, Denmark, Ministry of Social Affairs, Denmark, University of Copenhagen, Copenhagen Hospital Corporation, Medical Research Council, Wørzners Foundation.

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Schizophreniform Disorders, Schizoaffective Disorder, Psychosis, Brief Reactive, Schizophrenia, Borderline
Keywords
Schizophrenia, First episode psychosis, Psychosocial intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Integrated treatment, family involvement
Intervention Type
Behavioral
Intervention Name(s)
Social skills training
Primary Outcome Measure Information:
Title
Psychotic symptoms at one and two year follow-up
Title
Negative symptoms at one and two year follow-up
Secondary Outcome Measure Information:
Title
Adherence at one and two year follow-up
Title
Depression at one and two year follow-up
Title
Suicidal behaviour at one and two year follow-up
Title
Use satisfaction at one and two year follow-up
Title
Quality of life at one and two year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete Nordentoft, Ph.D.
Organizational Affiliation
Bispebjerg Hospital, department of psychiatry, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital, department of psychiatry
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
11016522
Citation
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.
Results Reference
background
PubMed Identifier
12271808
Citation
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.
Results Reference
result
PubMed Identifier
16141449
Citation
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.
Results Reference
result
PubMed Identifier
16122909
Citation
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.
Results Reference
result
PubMed Identifier
16055817
Citation
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.
Results Reference
result
PubMed Identifier
16055815
Citation
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.
Results Reference
result
PubMed Identifier
15863743
Citation
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.
Results Reference
result
PubMed Identifier
26948484
Citation
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.
Results Reference
derived
PubMed Identifier
18447961
Citation
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.
Results Reference
derived

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Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis

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