NCT02220504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

9.6 years

First QC Date

August 13, 2014

Last Update Submit

March 13, 2017

Conditions

SchizophreniaSchizophrenia RelapseSchizophrenia Spectrum and Other Psychotic Disorders

Keywords

TreatmentMaintenance

Outcome Measures

Primary Outcomes (1)

  • Relapse rate.

    The main outcome was the percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.

    At 3 years.

Secondary Outcomes (3)

  • Clinical psychopathology.

    At 3 years.

  • Time to relapse.

    At 3 years.

  • Clinical functionality.

    At 3 years.

Study Arms (2)

Intervention group

EXPERIMENTAL

Antipsychotic treatment discontinuation (DT)

Other: Antipsychotic treatment discontinuation

Control group

ACTIVE COMPARATOR

Maintenance antipsychotic treatment (MT)

Other: Maintenance antipsychotic treatment

Interventions

Antipsychotic treatment discontinuationOTHER

Withdrawal of antipsychotic medication to stabilized patients.

Intervention group
Maintenance antipsychotic treatmentOTHER

Maintenance antipsychotic medication to stabilized patients.

Control group

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Related Publications (1)

  • Mayoral-van Son J, de la Foz VO, Martinez-Garcia O, Moreno T, Parrilla-Escobar M, Valdizan EM, Crespo-Facorro B. Clinical outcome after antipsychotic treatment discontinuation in functionally recovered first-episode nonaffective psychosis individuals: a 3-year naturalistic follow-up study. J Clin Psychiatry. 2016 Apr;77(4):492-500. doi: 10.4088/JCP.14m09540.

    PMID: 26759992DERIVED

MeSH Terms

Conditions

SchizophreniaSchizophrenia Spectrum and Other Psychotic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Benedicto Crespo-Facorro, Professor

    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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 20, 2014

Study Start

July 1, 2004

Primary Completion

February 1, 2014

Study Completion

July 1, 2014

Last Updated

March 14, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)