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

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ClinicalTrials.gov Identifier: NCT03090490
Recruitment Status : Enrolling by invitation
First Posted : March 24, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Centro de Investigación Biomédica en Red de Salud Mental
Instituto de Investigación Marqués de Valdecilla
Information provided by (Responsible Party):
Benedicto Crespo-Facorro, Fundación Marques de Valdecilla

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizophrenia Relapse Schizophrenia Spectrum and Other Psychotic Disorders Other: Antipsychotic treatment discontinuation Other: Maintenance treatment discontinuation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: a 10-year Follow-up
Actual Study Start Date : September 2014
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Antipsychotic treatment discontinuation (DT)
Other: Antipsychotic treatment discontinuation
Withdrawal of antipsychotic medication to stabilized patients

Active Comparator: Control group
Maintenance antipsychotic treatment (MT)
Other: Maintenance treatment discontinuation
Maintenance antipsychotic medication to stabilized patients




Primary Outcome Measures :
  1. Relapse rate [ Time Frame: At 10 years ]
    The percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.


Secondary Outcome Measures :
  1. Change in general psychopathology measured by BPRS [ Time Frame: At 10 years ]
    Measured by changes in total score of the Brief Psychiatric Rating Scale (BPRS).

  2. Change in overall clinical status measured by CGI [ Time Frame: At 10 years ]
    Measured by changes in total score of the Clinical Global Impression (CGI).

  3. Change in negative symptoms measured by SANS [ Time Frame: At 10 years ]
    Measured by changes in total score of the Scale for the Assessment of Negative Symptoms (SANS).

  4. Change in negative symptoms measured by SAPS [ Time Frame: At 10 years ]
    Measured by changes in total score of the Scale for the Assessment of Positive Symptoms (SAPS).

  5. Time to relapse [ Time Frame: At 10 years ]
    Time to relapse in the two groups of patients, discontinuation and maintenance.

  6. Functionality status measured by DAS [ Time Frame: At 10 years ]
    Measured by changes in total score of the Disability Assessment Scale (DAS).



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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090490


Locations
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Spain
University Hospital Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Sponsors and Collaborators
Fundación Marques de Valdecilla
Centro de Investigación Biomédica en Red de Salud Mental
Instituto de Investigación Marqués de Valdecilla
Investigators
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Principal Investigator: 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

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Responsible Party: Benedicto Crespo-Facorro, Associate Professor of Psychiatry, Fundación Marques de Valdecilla
ClinicalTrials.gov Identifier: NCT03090490     History of Changes
Other Study ID Numbers: ADARFEP_10Y
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benedicto Crespo-Facorro, Fundación Marques de Valdecilla:
Treatment
Maintenance
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs