Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis - Full Text View

Purpose

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.

Condition	Intervention
Psychotic Disorders Schizophreniform Disorders Schizoaffective Disorder Psychosis, Brief Reactive Schizophrenia, Borderline	Behavioral: Integrated treatment, family involvement Behavioral: Social skills training

MedlinePlus related topics:

Depression Psychotic Disorders Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis

Further study details as provided by Bispebjerg Hospital:

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

Estimated Enrollment:	600
Study Start Date:	January 1998
Estimated Study Completion Date:	December 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157313

Locations


Denmark
	Bispebjerg Hospital, department of psychiatry
	Copenhagen, Denmark, 2400

Sponsors and Collaborators

Bispebjerg Hospital

Ministry of the Interior and Health, Denmark

Ministry of Social Affairs, Denmark

University of Copenhagen

Copenhagen Hospital Corporation

Medical Research Council

Wørzners Foundation.

Investigators


Principal Investigator:	Merete Nordentoft, Ph.D.	Bispebjerg Hospital, department of psychiatry, University of Copenhagen

More Information

Publications of Results:

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.

Petersen L, Jeppesen P, Thorup A, Abel MB, Ohlenschlager J, Christensen TS, 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 6; [Epub ahead of print]

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 Aug 22; [Epub ahead of print]

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.

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.

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.

Other 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.

Publications indexed to this study:

Jeppesen P, Petersen L, Thorup A, Abel MB, Øhlenschlaeger J, Christensen TØ, Krarup G, Jørgensen 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. Epub 2008 Apr 30.

Study ID Numbers:	OPUS trial
First Received:	September 8, 2005
Last Updated:	April 25, 2006
ClinicalTrials.gov Identifier:	NCT00157313
Health Authority:	Denmark: National Board of Health

Keywords provided by Bispebjerg Hospital:

Schizophrenia

First episode psychosis

Psychosocial intervention

Study placed in the following topic categories:

Schizophrenia

Mental Disorders

Schizotypal Personality Disorder

Psychotic Disorders

Schizophrenia and Disorders with Psychotic Features

Personality Disorders

Additional relevant MeSH terms:

Pathologic Processes

Disease

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Bispebjerg Hospital Ministry of the Interior and Health, Denmark Ministry of Social Affairs, Denmark University of Copenhagen Copenhagen Hospital Corporation Medical Research Council Wørzners Foundation.
Information provided by:	Bispebjerg Hospital
ClinicalTrials.gov Identifier:	NCT00157313