Viewing Study NCT00221585



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Last Modification Date: 2024-10-26 @ 9:19 AM
Study NCT ID: NCT00221585
Status: UNKNOWN
Last Update Posted: 2006-11-07
First Post: 2005-09-16

Brief Title: The National Danish Schizophrenia Project
Sponsor: University of Copenhagen
Organization: University of Copenhagen

Study Overview

Official Title: None
Status: UNKNOWN
Status Verified Date: 1997-07
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 ie a scheduled manualised supportive individual psychotherapy 1 session of 45 min per week for a period of 1-3 years andor 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 ie a scheduled two-year long programme consisting of assertive community treatment psycho-educational multi-family treatment am 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None