Back to resultsContinued Early Intervention for Recent-onset Schizophrenia
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
integrated psychosocial treatment (behavior)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, psychosocial treatment, outcome
Eligibility Criteria
Inclusion Criteria: first-episode schizophrenia Exclusion Criteria: acute psychosis
Sites / Locations
- Norwegian University of Science and Technology
Outcomes
Primary Outcome Measures
Rehospitalizations and psychotic relapse at two years
Secondary Outcome Measures
Psychopathology, psychosocial changes, functioning, antipsychotic medication
Full Information
NCT ID
NCT00184509
First Posted
September 15, 2005
Last Updated
January 25, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
The Research Council of Norway
1. Study Identification
Unique Protocol Identification Number
NCT00184509
Brief Title
Continued Early Intervention for Recent-onset Schizophrenia
Official Title
Continued Early Intervention for Recent-onset Schizophrenia. A Randomized Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Study Start Date
February 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 1998 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
The Research Council of Norway
4. Oversight
5. Study Description
Brief Summary
The purpose of this study was to determine whether outreach integrated treatment of first episode schizophrenia was more effecive than standard outpatient treatment.
Detailed Description
Early intervention for schizophrenia has spawned considerable enthusiasm among clinicians without solid research evidence to suport its benefits and costs. The present study is a random-controlled study of integrated biomedical and psychosocial treatment on a population of recent-onset cases.
Comparison(s): 50 consecutive referrals with schizophrenic disorders of less than two years duration were allocated randomly to a comprehensive model of integrated treatment or standard care for two years. Main outcome measures was psychopathology, psychosocial functioning and hospital admissions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, psychosocial treatment, outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
integrated psychosocial treatment (behavior)
Primary Outcome Measure Information:
Title
Rehospitalizations and psychotic relapse at two years
Secondary Outcome Measure Information:
Title
Psychopathology, psychosocial changes, functioning, antipsychotic medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
first-episode schizophrenia
Exclusion Criteria:
acute psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K. Gunnar Gøtestam, MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Norwegian University of Science and Technology
City
Trondheim
ZIP/Postal Code
N-7000
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
28088223
Citation
Sigrunarson V, Grawe RW, Lydersen S, Morken G. Predictors of long term use of psychiatric services of patients with recent-onset schizophrenia: 12 years follow-up. BMC Psychiatry. 2017 Jan 14;17(1):18. doi: 10.1186/s12888-016-1186-x.
Results Reference
derived
PubMed Identifier
23898805
Citation
Sigrunarson V, Grawe RW, Morken G. Integrated treatment vs. treatment-as-usual for recent onset schizophrenia; 12 year follow-up on a randomized controlled trial. BMC Psychiatry. 2013 Jul 30;13:200. doi: 10.1186/1471-244X-13-200.
Results Reference
derived
PubMed Identifier
18447935
Citation
Morken G, Widen JH, Grawe RW. Non-adherence to antipsychotic medication, relapse and rehospitalisation in recent-onset schizophrenia. BMC Psychiatry. 2008 Apr 30;8:32. doi: 10.1186/1471-244X-8-32.
Results Reference
derived
PubMed Identifier
17474812
Citation
Morken G, Grawe RW, Widen JH. Effects of integrated treatment on antipsychotic medication adherence in a randomized trial in recent-onset schizophrenia. J Clin Psychiatry. 2007 Apr;68(4):566-71. doi: 10.4088/jcp.v68n0409.
Results Reference
derived
Learn more about this trial
Continued Early Intervention for Recent-onset Schizophrenia
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