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The National Danish Schizophrenia Project

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 1997 by University of Copenhagen.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00221585
First Posted: September 22, 2005
Last Update Posted: November 7, 2006
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.
Collaborator:
University of Aarhus
Information provided by:
University of Copenhagen
  Purpose
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 Intervention
Schizophrenia Behavioral: Psychosocial treatment/Psychodynamic treatment

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Study Start Date: October 1997
Estimated Study Completion Date: July 2005
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

  Eligibility

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00221585


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

Publications:
ClinicalTrials.gov Identifier: NCT00221585     History of Changes
Other Study ID Numbers: 5490-184
First Submitted: September 16, 2005
First Posted: September 22, 2005
Last Update Posted: November 7, 2006
Last Verified: July 1997

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