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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02916303
Other study ID # PAFIPEC
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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