<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02220504</url>
  </required_header>
  <id_info>
    <org_study_id>ADARFEP</org_study_id>
    <nct_id>NCT02220504</nct_id>
  </id_info>
  <brief_title>3-year Follow-up of Clinical Outcome After Antipsychotic Treatment Discontinuation in Psychosis Individuals</brief_title>
  <acronym>ADARFEP</acronym>
  <official_title>Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: A 3-year Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Marques de Valdecilla</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centro de Investigación Biomédica en Red de Salud Mental</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto de Investigación Marqués de Valdecilla</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación Marques de Valdecilla</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This open-label, non-randomized, prospective study will evaluate the risk of symptoms&#xD;
      recurrence during the three years after antipsychotic discontinuation in a sample of&#xD;
      functionally recovered first-episode patients with schizophrenia spectrum disorder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2004</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relapse rate.</measure>
    <time_frame>At 3 years.</time_frame>
    <description>The main outcome was the percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical psychopathology.</measure>
    <time_frame>At 3 years.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to relapse.</measure>
    <time_frame>At 3 years.</time_frame>
    <description>Time to relapse in the two groups of patients, discontinuation and maintenance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical functionality.</measure>
    <time_frame>At 3 years.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Schizophrenia Relapse</condition>
  <condition>Schizophrenia Spectrum and Other Psychotic Disorders</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Antipsychotic treatment discontinuation (DT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Maintenance antipsychotic treatment (MT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Antipsychotic treatment discontinuation</intervention_name>
    <description>Withdrawal of antipsychotic medication to stabilized patients.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Maintenance antipsychotic treatment</intervention_name>
    <description>Maintenance antipsychotic medication to stabilized patients.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the&#xD;
             University Hospital Marqués de Valdecilla (Santander, Spain).&#xD;
&#xD;
          -  A minimum of 18 months on antipsychotic treatment.&#xD;
&#xD;
          -  Meeting clinical remission criteria for at least the 12 months prior to inclusion.&#xD;
&#xD;
          -  Meeting the functional recovery criteria for at least the 6 months prior to inclusion.&#xD;
&#xD;
          -  Stabilized at the lowest effective doses for at least the 3 months prior to inclusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)&#xD;
             criteria for drug dependence.&#xD;
&#xD;
          -  Meeting DSM-IV criteria for mental retardation.&#xD;
&#xD;
          -  Having a history of neurological disease or head injury.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benedicto Crespo-Facorro, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>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</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Marques de Valdecilla</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>March 13, 2017</last_update_submitted>
  <last_update_submitted_qc>March 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación Marques de Valdecilla</investigator_affiliation>
    <investigator_full_name>Benedicto Crespo-Facorro</investigator_full_name>
    <investigator_title>Associate Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Treatment</keyword>
  <keyword>Maintenance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Schizophrenia Spectrum and Other Psychotic Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antipsychotic Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02220504
org study id: ADARFEP
nct id: NCT02220504
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Relapse rate.
time frame: At 3 years.
description: The main outcome was the percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.
measure: Clinical psychopathology.
time frame: At 3 years.
description: 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.
measure: Time to relapse.
time frame: At 3 years.
description: Time to relapse in the two groups of patients, discontinuation and maintenance.
measure: Clinical functionality.
time frame: At 3 years.
arm group label: Intervention group
arm group type: Experimental
description: Antipsychotic treatment discontinuation (DT)
arm group label: Control group
arm group type: Active Comparator
description: Maintenance antipsychotic treatment (MT)
intervention type: Other
intervention name: Antipsychotic treatment discontinuation
description: Withdrawal of antipsychotic medication to stabilized patients.
arm group label: Intervention group
intervention type: Other
intervention name: Maintenance antipsychotic treatment
description: Maintenance antipsychotic medication to stabilized patients.
arm group label: Control group
criteria: 
gender: All
minimum age: 15 Years
maximum age: 60 Years
healthy volunteers: No
last name: Benedicto Crespo-Facorro, Professor
role: Principal Investigator
affiliation: 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
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Fundación Marques de Valdecilla
investigator full name: Benedicto Crespo-Facorro
investigator title: Associate Professor of Psychiatry
mesh term: Schizophrenia
mesh term: Psychotic Disorders
mesh term: Schizophrenia Spectrum and Other Psychotic Disorders
mesh term: Antipsychotic Agents
sharing ipd: No