10-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals

Fundación Marques de Valdecilla68 enrolled

Overview

This open-label, non-randomized, prospective study will evaluate the risk of symptoms recurrence during the ten years after antipsychotic discontinuation in a sample of functionally recovered first-episode patients with schizophrenia spectrum disorder.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia Schizophrenia Relapse Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

Antipsychotic treatment discontinuationOTHER

Withdrawal of antipsychotic medication to stabilized patients

Maintenance treatment discontinuationOTHER

Maintenance antipsychotic medication to stabilized patients

Eligibility

Sex: ALLMin age: 15 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the University Hospital Marqués de Valdecilla (Santander, Spain). * A minimum of 18 months on antipsychotic treatment. * Meeting clinical remission criteria for at least the 12 months prior to inclusion. * Meeting the functional recovery criteria for at least the 6 months prior to inclusion. * Stabilized at the lowest effective doses for at least the 3 months prior to inclusion. Exclusion Criteria: * Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for drug dependence. * Meeting DSM-IV criteria for mental retardation. * Having a history of neurological disease or head injury.

Locations (1)

University Hospital Marques de Valdecilla

Santander, Cantabria, Spain

Outcomes

Primary Outcomes

Relapse rate

The percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.

Time frame: At 10 years

Secondary Outcomes

Change in general psychopathology measured by BPRS

Measured by changes in total score of the Brief Psychiatric Rating Scale (BPRS).

Time frame: At 10 years

Change in overall clinical status measured by CGI

Measured by changes in total score of the Clinical Global Impression (CGI).

Time frame: At 10 years

Change in negative symptoms measured by SANS

Measured by changes in total score of the Scale for the Assessment of Negative Symptoms (SANS).

Time frame: At 10 years

Change in negative symptoms measured by SAPS

Measured by changes in total score of the Scale for the Assessment of Positive Symptoms (SAPS).

Time frame: At 10 years

Time to relapse

Time to relapse in the two groups of patients, discontinuation and maintenance.

Time frame: At 10 years

Functionality status measured by DAS

Measured by changes in total score of the Disability Assessment Scale (DAS).

Time frame: At 10 years

Data from ClinicalTrials.gov

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