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

Not Applicable

Completed

• Conditions: Schizophrenia Relapse; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Interventions: Other: Maintenance antipsychotic treatment; Other: Antipsychotic treatment discontinuation

• Registration Number: NCT02220504
• Lead Sponsor: Fundación Marques de Valdecilla

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2014-02
• Study Completion: 2014-07
• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-18
• Study First Posted: 2014-08-20
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Maintenance antipsychotic treatment	Maintenance antipsychotic treatment (MT)
Intervention group	Antipsychotic treatment discontinuation	Antipsychotic treatment discontinuation (DT)

Primary Outcome Measures

Name	Time	Method
Relapse rate.	At 3 years.	The main outcome was the percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.

Secondary Outcome Measures

Name	Time	Method
Clinical functionality.	At 3 years.
Time to relapse.	At 3 years.	Time to relapse in the two groups of patients, discontinuation and maintenance.
Clinical psychopathology.	At 3 years.	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.

Trial Locations

Locations (1)

University Hospital Marques de Valdecilla; 🇪🇸 Santander, Cantabria, Spain