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

N/ACompletedNCT02220504

Fundación Marques de Valdecilla68 enrolled

Overview

This open-label, non-randomized, prospective study will evaluate the risk of symptoms recurrence during the three 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 antipsychotic treatmentOTHER

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 main outcome was the percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.

Time frame: At 3 years.

Secondary Outcomes

Clinical psychopathology.

Clinical psychopathology differences between groups are evaluated by the mean change from the study intake to 3 years for the severity of Clinical Global Impression scale (CGI), Brief Psychiatric Rating Scale expanded version of 24 items (BPRS), Scale for the Assessment of Positive Symptoms (SAPS) and Scale for the Assessment of Negative Symptoms (SANS) total scores.

Time frame: At 3 years.

Time to relapse.

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

Time frame: At 3 years.

Clinical functionality.

Time frame: At 3 years.

Data from ClinicalTrials.gov

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