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Clinical Trials/NCT02916303
NCT02916303
Unknown
Not Applicable

Cost-effectiveness of Early Intervention in First-episode Psychosis: Economic Evaluation of the PAFIP Program at Medium and Long-term

Fundación Marques de Valdecilla1 site in 1 country490 target enrollmentJune 2016
ConditionsSchizophrenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Fundación Marques de Valdecilla
Enrollment
490
Locations
1
Primary Endpoint
Cost of pharmacological and non-pharmacological treatments in monetary units (€)
Last Updated
6 years ago

Overview

Brief Summary

Schizophrenia has very significant economic consequences. Costs fall on many different parts of society, especially on individuals with schizophrenia and their families. The first five years after onset appears to be a critical period in which the symptoms are more responsive to treatment. In addition, if left untreated for a long time, psychosis can impact many areas of a person's life. The evidence base regarding the effectiveness of specialist early intervention services for psychosis has grown steadily and evidence from randomized controlled trials in Denmark, the United Kingdom and Spain has demonstrated the superiority of specialized early intervention programs over standard care on a broad range of outcomes including symptomatic and vocational, social functioning, and reduced inpatient care and treatment dropout, as measured over follow-up intervals of 2-3 years. Information about the cost-effectiveness of early intervention programs for first-episode psychosis is limited. The provision of such services requires investment by health departments and services, and the question of whether such services represent value for money has to date received little research attention. Only a few international studies, and none conducted in Spain, have investigated the cost effectiveness of early intervention in psychotic disorders at medium (3 years) and long-term (up to 10 years). In this study, the investigators aimed to analyse the cost-effectiveness of an intensive early-intervention programme, using data from First Episode Psychosis Clinical Program (PAFIP), the largest trial treating first episode non-affective psychosis in Spain to date.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
December 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fundación Marques de Valdecilla
Responsible Party
Principal Investigator
Principal Investigator

Benedicto Crespo-Facorro

Professor of Psychiatry

Fundación Marques de Valdecilla

Eligibility Criteria

Inclusion Criteria

  • Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for a principal diagnosis of schizophreniform, schizophrenia, schizoaffective, brief reactive psychosis, or psychosis non otherwise specified.
  • Living in the catchment area.
  • No prior treatment with antipsychotic medication or, if previously treated, a total life time of adequate antipsychotic treatment of less than 6 weeks.
  • Current psychotic symptoms of moderate severity or greater assessed by one of the five items of the Scale for the Assessment of Positive Symptoms (SAPS).
  • First episode patients with at least one assessement at 3 years or 10 years.

Exclusion Criteria

  • Meeting DSM-IV criteria for mental retardation.
  • Meeting DSM-IV criteria for drug dependence.

Outcomes

Primary Outcomes

Cost of pharmacological and non-pharmacological treatments in monetary units (€)

Time Frame: 3 years and 10 years

Secondary Outcomes

  • Cost of suicide attempt in monetary units (€)(3 years and 10 years)
  • Cost of inpatient treatment in monetary units (€)(3 years and 10 years)
  • Burden of unemployment rate in monetary units (€)(3 years and 10 years)
  • Expenditure in transportation in monetary units (€)(3 years and 10 years)

Study Sites (1)

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