The National Danish Schizophrenia Project

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00221585
• Other study ID #: 5490-184
• Status: Active, not recruiting
• Phase: N/A
• First received: September 16, 2005
• Last updated: November 6, 2006
• Start date: October 1997
• Est. completion date: July 2005

Study information

• Verified date: July 1997
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ministry of Health
• Study type: Observational

Clinical Trial 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’.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 35 Years

Eligibility

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.

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Psychosocial treatment/Psychodynamic treatment

Locations

Country	Name	City	State
Denmark	Psychiatric Hospitäl in Aarhus	Risskov	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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