Overview

This trial is active, not recruiting.

Conditions psychotic disorders, schizophreniform disorders, schizoaffective disorder, psychosis, brief reactive, schizophrenia, borderline
Treatments integrated treatment, family involvement, social skills training
Sponsor Bispebjerg Hospital
Collaborator Ministry of the Interior and Health, Denmark
Start date January 1998
End date December 2005
Trial size 600 participants
Trial identifier NCT00157313, OPUS 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Psychotic symptoms at one and two year follow-up
time frame:
Negative symptoms at one and two year follow-up
time frame:

Secondary Outcomes

Measure
Adherence at one and two year follow-up
time frame:
Depression at one and two year follow-up
time frame:
Suicidal behaviour at one and two year follow-up
time frame:
Use satisfaction at one and two year follow-up
time frame:
Quality of life at one and two year follow-up
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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:

Additional Information

Official title Randomised Clinical Trial of Integrated Treatment Versus Standard Treatment in First Episode Psychosis
Principal investigator Merete Nordentoft, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2006.
Information provided to ClinicalTrials.gov by Bispebjerg Hospital.