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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual 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 3-year Follow-up
Actual Study Start Date : July 2004
Actual Primary Completion Date : February 2014
Actual Study Completion Date : July 2014

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 antipsychotic treatment
Maintenance antipsychotic medication to stabilized patients.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Time to relapse. [ Time Frame: At 3 years. ]
    Time to relapse in the two groups of patients, discontinuation and maintenance.

  3. Clinical functionality. [ Time Frame: At 3 years. ]


Information from the National Library of Medicine

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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): NCT02220504


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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Benedicto Crespo-Facorro, Associate Professor of Psychiatry, Fundación Marques de Valdecilla
ClinicalTrials.gov Identifier: NCT02220504    
Other Study ID Numbers: ADARFEP
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
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