NCT03090490

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

3.3 years

First QC Date

March 14, 2017

Last Update Submit

January 13, 2020

Conditions

SchizophreniaSchizophrenia RelapseSchizophrenia Spectrum and Other Psychotic Disorders

Keywords

TreatmentMaintenance

Outcome Measures

Primary Outcomes (1)

  • Relapse rate

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

    At 10 years

Secondary Outcomes (6)

  • Change in general psychopathology measured by BPRS

    At 10 years

  • Change in overall clinical status measured by CGI

    At 10 years

  • Change in negative symptoms measured by SANS

    At 10 years

  • Change in negative symptoms measured by SAPS

    At 10 years

  • Time to relapse

    At 10 years

  • +1 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Antipsychotic treatment discontinuation (DT)

Other: Antipsychotic treatment discontinuation

Control group

ACTIVE COMPARATOR

Maintenance antipsychotic treatment (MT)

Other: Maintenance treatment discontinuation

Interventions

Antipsychotic treatment discontinuationOTHER

Withdrawal of antipsychotic medication to stabilized patients

Intervention group
Maintenance treatment discontinuationOTHER

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

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

March 14, 2017

First Posted

March 24, 2017

Study Start

September 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2020

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)