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Trial record 1 of 1 for:    NCT02220504
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3-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals (ADARFEP)

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ClinicalTrials.gov Identifier: NCT02220504
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : March 14, 2017
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

Tracking Information
First Submitted Date  ICMJE August 13, 2014
First Posted Date  ICMJE August 20, 2014
Last Update Posted Date March 14, 2017
Actual Study Start Date  ICMJE July 2004
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
Relapse rate. [ Time Frame: At 3 years. ]
The main outcome was the percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
  • Clinical psychopathology. [ Time Frame: At 3 years. ]
    Clinical psychopathology differences between groups are evaluated by the mean change from the study intake to 3 years for the severity of Clinical Global Impression scale (CGI), Brief Psychiatric Rating Scale expanded version of 24 items (BPRS), Scale for the Assessment of Positive Symptoms (SAPS) and Scale for the Assessment of Negative Symptoms (SANS) total scores.
  • Time to relapse. [ Time Frame: At 3 years. ]
    Time to relapse in the two groups of patients, discontinuation and maintenance.
  • Clinical functionality. [ Time Frame: At 3 years. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
  • Clinical psychopathology. [ Time Frame: At 3 years. ]
    Clinical psychopathology differences between groups were evaluated by the mean change from the study intake to 3 years for the CGI (the severity of the Clinical Global Impression scale), BPRS (the Brief Psychiatric Rating Scale expanded version of 24 items), SAPS (the Scale for the Assessment of Positive Symptoms) and SANS (the Scale for the Assessment of Negative Symptoms) total scores.
  • Time to relapse. [ Time Frame: At 3 years. ]
    Time to relapse in the two groups of patients, discontinuation and maintenance.
  • Clinical functionality. [ Time Frame: At 3 years. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 3-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals
Official Title  ICMJE Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: A 3-year Follow-up
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizophrenia Relapse
  • Schizophrenia Spectrum and Other Psychotic Disorders
Intervention  ICMJE
  • Other: Antipsychotic treatment discontinuation
    Withdrawal of antipsychotic medication to stabilized patients.
  • Other: Maintenance antipsychotic treatment
    Maintenance antipsychotic medication to stabilized patients.
Study Arms  ICMJE
  • Experimental: Intervention group
    Antipsychotic treatment discontinuation (DT)
    Intervention: Other: Antipsychotic treatment discontinuation
  • Active Comparator: Control group
    Maintenance antipsychotic treatment (MT)
    Intervention: Other: Maintenance antipsychotic treatment
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2014)
68
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02220504
Other Study ID Numbers  ICMJE ADARFEP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Benedicto Crespo-Facorro, Fundación Marques de Valdecilla
Study Sponsor  ICMJE Fundación Marques de Valdecilla
Collaborators  ICMJE
  • Centro de Investigación Biomédica en Red de Salud Mental
  • Instituto de Investigación Marqués de Valdecilla
Investigators  ICMJE
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
PRS Account Fundación Marques de Valdecilla
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP