Cost-effectiveness of Interventions in First-episode Psychosis

Schizophrenia Clinical Trial

— PAFIPEC  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02916303
• Other study ID #: PAFIPEC
• Status: Enrolling by invitation
• Start date: June 2016
• Est. completion date: December 2020

Study information

• Verified date: February 2019
• Source: Fundación Marques de Valdecilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 490
• Est. completion date: December 2020
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Locations

Country	Name	City	State
Spain	University Hospital Marqués de Valdecilla	Santander	Cantabria

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Marques de Valdecilla	Centro de Investigación Biomédica en Red de Salud Mental, Instituto de Investigación Marqués de Valdecilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost of pharmacological and non-pharmacological treatments in monetary units (€)		3 years and 10 years
Secondary	Cost of inpatient treatment in monetary units (€)		3 years and 10 years
Secondary	Cost of suicide attempt in monetary units (€)		3 years and 10 years
Secondary	Burden of unemployment rate in monetary units (€)		3 years and 10 years
Secondary	Expenditure in transportation in monetary units (€)		3 years and 10 years