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10-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals (ADARFEP_10Y)

F

Fundación Marques de Valdecilla

Status

Unknown

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders
Schizophrenia
Schizophrenia Relapse

Treatments

Other: Maintenance treatment discontinuation
Other: Antipsychotic treatment discontinuation

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT03090490
ADARFEP_10Y

Details and patient eligibility

About

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.

Enrollment

68 estimated patients

Sex

All

Ages

15 to 60 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

68 participants in 2 patient groups

Intervention group
Experimental group
Description:
Antipsychotic treatment discontinuation (DT)
Treatment:
Other: Antipsychotic treatment discontinuation
Control group
Active Comparator group
Description:
Maintenance antipsychotic treatment (MT)
Treatment:
Other: Maintenance treatment discontinuation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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