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The National Danish Schizophrenia Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00221585
Recruitment Status : Unknown
Verified July 1997 by University of Copenhagen.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : November 7, 2006
University of Aarhus
Information provided by:
University of Copenhagen

Brief Summary:
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’.

Condition or disease Intervention/treatment
Schizophrenia Behavioral: Psychosocial treatment/Psychodynamic treatment

Detailed Description:

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

Study Type : Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : October 1997
Estimated Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00221585

Psychiatric Hospitäl in Aarhus
Risskov, Aarhus, Denmark, 8240
Sponsors and Collaborators
University of Copenhagen
University of Aarhus
Study Director: Bent Rosenbaum, DMSci Psychiatric Center Glostrup, Dernmark

Publications of Results: Identifier: NCT00221585     History of Changes
Other Study ID Numbers: 5490-184
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 7, 2006
Last Verified: July 1997

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders