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

Schizoaffective Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00157313
• Other study ID #: OPUS trial
• Status: Active, not recruiting
• Phase: N/A
• First received: September 8, 2005
• Last updated: January 27, 2016
• Start date: January 1998
• Est. completion date: December 2022

Study information

• Verified date: September 2005
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Psychosis, Brief Reactive
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophrenia, Borderline
• Schizophreniform Disorders
• Schizotypal Personality Disorder

Intervention

Behavioral:
• Integrated treatment, family involvement

• Social skills training

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital, department of psychiatry	Copenhagen

Sponsors (7)

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

Country where clinical trial is conducted

Denmark, 

References & Publications (7)

Jeppesen P, Petersen L, Thorup A, Abel MB, Oehlenschlaeger J, Christensen TØ, Krarup G, Hemmingsen R, Jørgensen P, Nordentoft M. Integrated treatment of first-episode psychosis: effect of treatment on family burden: OPUS trial. Br J Psychiatry Suppl. 2005 — View Citation

Jørgensen 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. — View Citation

Nordentoft M, Jeppesen P, Abel M, Kassow P, Petersen L, Thorup A, Krarup G, Hemmingsen R, Jørgensen P. OPUS study: suicidal behaviour, suicidal ideation and hopelessness among patients with first-episode psychosis. One-year follow-up of a randomised contr — View Citation

Petersen L, Jeppesen P, Thorup A, Abel MB, Øhlenschlaeger J, Christensen TØ, Krarup G, Jørgensen P, Nordentoft M. A randomised multicentre trial of integrated versus standard treatment for patients with a first episode of psychotic illness. BMJ. 2005 Sep — View Citation

Petersen L, Nordentoft M, Jeppesen P, Ohlenschaeger J, Thorup A, Christensen TØ, Krarup G, Dahlstrøm J, Haastrup B, Jørgensen P. Improving 1-year outcome in first-episode psychosis: OPUS trial. Br J Psychiatry Suppl. 2005 Aug;48:s98-103. — View Citation

Rosenbaum B, Valbak K, Harder S, Knudsen P, Køster A, Lajer M, Lindhardt A, Winther G, Petersen L, Jørgensen P, Nordentoft M, Andreasen AH. The Danish National Schizophrenia Project: prospective, comparative longitudinal treatment study of first-episode p — View Citation

Thorup A, Petersen L, Jeppesen P, Ohlenschlaeger J, Christensen T, Krarup G, Jørgensen 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):95-1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychotic symptoms at one and two year follow-up
Primary	Negative symptoms at one and two year follow-up
Secondary	Adherence at one and two year follow-up
Secondary	Depression at one and two year follow-up
Secondary	Suicidal behaviour at one and two year follow-up
Secondary	Use satisfaction at one and two year follow-up
Secondary	Quality of life at one and two year follow-up