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

Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: a 10-year Follow-up

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03090490

Acronym

ADARFEP_10Y

Enrollment

Registered

2017-03-24

Start date

2014-09-30

Completion date

2020-12-31

Last updated

2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, Schizophrenia Relapse, Schizophrenia Spectrum and Other Psychotic Disorders

Keywords

Treatment, Maintenance

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.

Interventions

OTHERAntipsychotic treatment discontinuation

Withdrawal of antipsychotic medication to stabilized patients

OTHERMaintenance treatment discontinuation

Maintenance antipsychotic medication to stabilized patients

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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 general psychopathology measured by BPRS	At 10 years	Measured by changes in total score of the Brief Psychiatric Rating Scale (BPRS).
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).
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).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026