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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Schizophrenia Schizophrenia Relapse Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Antipsychotic treatment discontinuation (DT)

Group Type EXPERIMENTAL

Antipsychotic treatment discontinuation

Intervention Type OTHER

Withdrawal of antipsychotic medication to stabilized patients

Control group

Maintenance antipsychotic treatment (MT)

Group Type ACTIVE_COMPARATOR

Maintenance treatment discontinuation

Intervention Type OTHER

Maintenance antipsychotic medication to stabilized patients

Interventions

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Antipsychotic treatment discontinuation

Withdrawal of antipsychotic medication to stabilized patients

Intervention Type OTHER

Maintenance treatment discontinuation

Maintenance antipsychotic medication to stabilized patients

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Benedicto Crespo-Facorro

Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benedicto Crespo-Facorro, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital Marqués de Valdecilla, IDIVAL, Department of Psychiatry, School of Medicine, University of Cantabria, Santander, Spain. CIBERSAM Centro Investigación Biomédica en Red Salud Mental, Madrid, Spain