Continued Early Intervention for Recent-Onset Schizophrenia

This study has been terminated.

Sponsor:

Collaborator:

The Research Council of Norway

Information provided by:

Norwegian University of Science and Technology

ClinicalTrials.gov Identifier:

NCT00184509

First received: September 15, 2005

Last updated: NA

Last verified: September 2005

History: No changes posted

Tracking Information

First Received Date ^ICMJE

September 15, 2005

Last Updated Date

September 15, 2005

Start Date ^ICMJE

February 1993

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Rehospitalizations and psychotic relapse at two years

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Psychopathology, psychosocial changes, functioning, antipsychotic medication

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Continued Early Intervention for Recent-Onset Schizophrenia

Official Title ^ICMJE

Continued Early Intervention for Recent-Onset Schizophrenia. A Randomized Controlled Study.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Behavioral: integrated psychosocial treatment (behavior)

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

May 1998

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

first-episode schizophrenia

Exclusion Criteria:

acute psychosis

Gender

Both

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT00184509

Other Study ID Numbers ^ICMJE

SHDIR-1992-1995; NFR-1997-1999

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Norwegian University of Science and Technology

Collaborators ^ICMJE

The Research Council of Norway

Investigators ^ICMJE

Study Director:

K. Gunnar Gøtestam, MD

Norwegian University of Science and Technology

Information Provided By

Norwegian University of Science and Technology

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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