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

Not Applicable

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

• Registration Number: NCT03090490
• Lead Sponsor: Fundación Marques de Valdecilla

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2017-03-14
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-24
• Primary Completion: 2017-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-14
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• 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 treatment discontinuation	Maintenance antipsychotic treatment (MT)
Intervention group	Antipsychotic treatment discontinuation	Antipsychotic treatment discontinuation (DT)

Primary Outcome Measures

Name	Time	Method
Relapse rate	At 10 years	The percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.

Secondary Outcome Measures

Name	Time	Method
Change in general psychopathology measured by BPRS	At 10 years	Measured by changes in total score of the Brief Psychiatric Rating Scale (BPRS).
Change in overall clinical status measured by CGI	At 10 years	Measured by changes in total score of the Clinical Global Impression (CGI).
Change in negative symptoms measured by SANS	At 10 years	Measured by changes in total score of the Scale for the Assessment of Negative Symptoms (SANS).
Change in negative symptoms measured by SAPS	At 10 years	Measured by changes in total score of the Scale for the Assessment of Positive Symptoms (SAPS).
Time to relapse	At 10 years	Time to relapse in the two groups of patients, discontinuation and maintenance.
Functionality status measured by DAS	At 10 years	Measured by changes in total score of the Disability Assessment Scale (DAS).

Trial Locations

Locations (1)

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