The National Danish Schizophrenia Project

NCT ID: NCT00221585

Last Updated: 2006-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Study Start Date

1997-10-31

Study Completion Date

2005-07-31

Brief Summary

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A prospective, longitudinal, multi-centre investigation (16 centres), including 562 patients, consecutively referred during two years, with a first-episode psychosis of ICD-10, F-2 type. Patients were treated with: 1) 'Supportive psychodynamic psychotherapy as a supplement to treatment as usual', 2) an 'Integrated, assertive, psychosocial and educational treatment programme', and 3) 'Treatment as usual'.

Detailed Description

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The study is a prospective, comparative, longitudinal study with an intervention period of a minimum of two years and a registration of data at baseline and 1, 2 and 5 years after inclusion. Three sub-cohorts with different treatment modalities were designed:

Treatment1: 119 patients were, in addition to TaU, offered SPP, i.e. a scheduled manualised supportive individual psychotherapy (1 session of 45 min. per week, for a period of 1-3 years) and/or group psychotherapy (1 session of 60 min. per week for a period of 1-3 years). Anti-psychotic medication was given in doses based on individual needs; Treatment 2: 139 patients were offered IT, i.e. a scheduled, two-year long programme consisting of assertive community treatment, psycho-educational multi-family treatment (a.m. McFarlane, consisting of 4-6 families including the patients, meeting 1½ hour every second week for 1½ year), social skills training (concerning medication, self-management, coping with symptoms, conversational skills, problem and conflict solving skills), and antipsychotic medication (low dose strategy). This project, OPUS, has been described in detail elsewhere

Conditions

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Schizophrenia

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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Psychosocial treatment/Psychodynamic treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

consecutively referred patients, age 16-35 years, who suffered from a first-episode psychosis of the schizophrenic spectrum disorder (ICD-10, DF 20-29).

\-

Exclusion Criteria

* patients suffering from mental retardation or other organic brain damage, and patients who were not proficient enough in Danish due to their foreign origins.
Minimum Eligible Age

16 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Principal Investigators

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Bent Rosenbaum, DMSci

Role: STUDY_DIRECTOR

Psychiatric Center Glostrup, Dernmark

Locations

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Psychiatric Hospitäl in Aarhus

Risskov, Aarhus, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 15863743 (View on PubMed)

Other Identifiers

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5490-184

Identifier Type: -

Identifier Source: org_study_id