- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00184509
Continued Early Intervention for Recent-onset Schizophrenia
Continued Early Intervention for Recent-onset Schizophrenia. A Randomized Controlled Study.
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Trondheim, Norway, N-7000
- Norwegian University of Science and Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- first-episode schizophrenia
Exclusion Criteria:
- acute psychosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Rehospitalizations and psychotic relapse at two years
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Secondary Outcome Measures
Outcome Measure |
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Psychopathology, psychosocial changes, functioning, antipsychotic medication
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: K. Gunnar Gøtestam, MD, Norwegian University of Science and Technology
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHDIR-1992-1995; NFR-1997-1999
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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