<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/NCT01663974</url>
  </required_header>
  <id_info>
    <org_study_id>NIS-NFR-XXX-2012/1</org_study_id>
    <nct_id>NCT01663974</nct_id>
  </id_info>
  <brief_title>Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder</brief_title>
  <acronym>POLARIS</acronym>
  <official_title>Evaluation of Sub-syndromal Symptoms After Acute Depressive Episode in Bipolar Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to evaluate:&#xD;
&#xD;
        -  the frequency of subsyndromal symptoms or disorders observed during interepisode phases&#xD;
           in bipolar patients, particularly after a depressive episode in which these subsyndromal&#xD;
           disorders are the most frequent&#xD;
&#xD;
        -  the functional impact of these disorders, factors or symptom thresholds associated with&#xD;
           functional remission, and factors associated with symptomatic remission over a&#xD;
           sufficient follow-up (12 months).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluation of sub-syndromal symptoms after acute depressive episode in bipolar disorder&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The prevalence of sub-syndromal symptoms after an acute depressive episode in Bipolar Disorder patients, as measured by scoring on YMRS and MADRS scales and MVAS-BP self-administered questionnaire.</measure>
    <time_frame>12 months</time_frame>
    <description>The 10 items of the MADRS are scored as 0, 2, 4 and 6 (0 = no depressive symptoms; 6 = severe depressive symptoms). Total scores, ranging from 0 to 60, will be calculated by adding the values for the 10 items. The YMRS scale is composed of 11 items, scored from 0 to 4 (0 = no manic symptoms; 4 = severe manic symptoms). Total scores will be calculated by adding the scores for the 11 items. MVAS-BP questionnaire is composed of 26 visual analogue scales, each item is scored from 0 (extreme depressive pole) to 100 (extreme manic pole). Absence of symptoms is at the middle of the scale (value 50).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of sub-syndromal symptoms on functioning of real-life French Bipolar Disorder patients as measured by scoring on Functioning Assessment Short Test (FAST) scale.</measure>
    <time_frame>12 months</time_frame>
    <description>Functioning Assessment Short Test (FAST) is a brief instrument designed to assess the main functioning problems experienced by psychiatric patients. The 24 items of the FAST questionnaire are scored from 0 to 3 (a score of 0 indicates that the patient does not experience any difficulties, while a score of 3 indicates that the patient experiences major difficulties). Total scores will be calculated by adding the scores for each item. Functional remission will be evaluated on the FAST scale ; functional remission will be defined as a score &lt; 11 on the FAST questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and type of factors associated with a symptomatic and functioning remission after recovery from an acute depressive bipolar episode in real-life French population.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the management patterns (such as number and drug-class of treatments, number and type of resource used) associated with the presence and absence of sub-syndromal symptoms after an acute bipolar depressive episode.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">125</enrollment>
  <condition>Bipolar Disorder</condition>
  <condition>Sub-syndromal Symptoms</condition>
  <arm_group>
    <arm_group_label>Bipolar disorder patients</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        hospital/medico-psychological centre (CMP) [clinic] / private practice&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient with a diagnosis of bipolar disorder according to DSM-IV criteria&#xD;
             currently followed up by the investigator in hospital or open-care practice and&#xD;
             informed of his/her disease.&#xD;
&#xD;
          -  For whom the previous episode was a bipolar depression assessed clinically stabilized&#xD;
             for at least 4 weeks by the investigator.&#xD;
&#xD;
          -  Able to complete the self-assessment diary weekly&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  Patient included in a clinical trial on an investigational drug or having received an&#xD;
             investigational drug in the preceding 30 days.&#xD;
&#xD;
          -  Person deprived of freedom or subject to a guardianship (or ward) order or unable to&#xD;
             undergo medical monitoring for geographical, social or psychological reasons.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J M AZORIN, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital Sainte Marguerite - MARSEILLE - FRANCE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>A SOLVET, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca - FRANCE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aix En Provence</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ajaccio</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Altkirch</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Armentieres</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Avignon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bailleul</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bohars</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bourg En Bresse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cahors</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Castries</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Challes Les Eaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chateaulin</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Clermont Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Colmar</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Conty</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Coulommiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Creteil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Crosne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>DAX</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Decines Charpieu</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Digne Les Bains</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Douai</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Durtol</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dury</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fains Veel</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fitz James</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hazebrouck</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hericourt</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Issoudun</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>La Roche Sur Foron</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>La Roche Sur Yon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>La Rochelle</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>La Tronche</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>La Varenne St Hilaire</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lamballe</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Laval</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Le Mans</city>
        <country>France</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Le Puy En Velay</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Le Vesinet</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Libourne</city>
        <country>France</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Luynes</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mayenne</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Metz</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Monaco</city>
        <country>France</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mont de Marsan</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montfermeil</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montmorency</city>
        <country>France</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nemours</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nevers</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Noisiel</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Novillars</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Paimpol</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Paris</city>
        <country>France</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>PAU</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rouffach</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rueil Malmaison</city>
        <country>France</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sallanches</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sevrey</city>
        <country>France</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Soissons</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sotteville Les Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St Denis Les Bourg</city>
        <country>France</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St Denis</city>
        <country>France</country>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St Dizier</city>
        <country>France</country>
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    </facility>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St Egreve</city>
        <country>France</country>
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    </facility>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>St Nazaire</city>
        <country>France</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>St Vincent de Tyrosse</city>
        <country>France</country>
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    <facility>
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        <city>Strasbourg</city>
        <country>France</country>
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    <facility>
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      <address>
        <city>Thuir</city>
        <country>France</country>
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      <name>Research Site</name>
      <address>
        <city>Toulon</city>
        <country>France</country>
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    <facility>
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      <address>
        <city>Toulouse</city>
        <country>France</country>
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        <city>Tours</city>
        <country>France</country>
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      <address>
        <city>Valence</city>
        <country>France</country>
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      <address>
        <city>Vernon</city>
        <country>France</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Versailles</city>
        <country>France</country>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Vincennes</city>
        <country>France</country>
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    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=929&amp;filename=NIS-NFR-XXX-2012-1_Clinical_Study_Report_Synopsis.pdf</url>
    <description>NIS-NFR-XXX-2012-1_Clinical_Study_Report_Synopsis.pdf</description>
  </link>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>March 6, 2015</last_update_submitted>
  <last_update_submitted_qc>March 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bipolar Disorders</keyword>
  <keyword>Sub-syndromal symptoms</keyword>
  <keyword>Acute depressive episode</keyword>
  <keyword>Symptomatic remission</keyword>
  <keyword>Functioning remission</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT01663974
org study id: NIS-NFR-XXX-2012/1
nct id: NCT01663974
lead sponsor: 
has dmc: No
The study aims to evaluate:

        -  the frequency of subsyndromal symptoms or disorders observed during interepisode phases
           in bipolar patients, particularly after a depressive episode in which these subsyndromal
           disorders are the most frequent

        -  the functional impact of these disorders, factors or symptom thresholds associated with
           functional remission, and factors associated with symptomatic remission over a
           sufficient follow-up (12 months).
Evaluation of sub-syndromal symptoms after acute depressive episode in bipolar disorder
observational model: Cohort
time perspective: Prospective
measure: The prevalence of sub-syndromal symptoms after an acute depressive episode in Bipolar Disorder patients, as measured by scoring on YMRS and MADRS scales and MVAS-BP self-administered questionnaire.
time frame: 12 months
description: The 10 items of the MADRS are scored as 0, 2, 4 and 6 (0 = no depressive symptoms; 6 = severe depressive symptoms). Total scores, ranging from 0 to 60, will be calculated by adding the values for the 10 items. The YMRS scale is composed of 11 items, scored from 0 to 4 (0 = no manic symptoms; 4 = severe manic symptoms). Total scores will be calculated by adding the scores for the 11 items. MVAS-BP questionnaire is composed of 26 visual analogue scales, each item is scored from 0 (extreme depressive pole) to 100 (extreme manic pole). Absence of symptoms is at the middle of the scale (value 50).
measure: Impact of sub-syndromal symptoms on functioning of real-life French Bipolar Disorder patients as measured by scoring on Functioning Assessment Short Test (FAST) scale.
time frame: 12 months
description: Functioning Assessment Short Test (FAST) is a brief instrument designed to assess the main functioning problems experienced by psychiatric patients. The 24 items of the FAST questionnaire are scored from 0 to 3 (a score of 0 indicates that the patient does not experience any difficulties, while a score of 3 indicates that the patient experiences major difficulties). Total scores will be calculated by adding the scores for each item. Functional remission will be evaluated on the FAST scale ; functional remission will be defined as a score < 11 on the FAST questionnaire.
measure: Number and type of factors associated with a symptomatic and functioning remission after recovery from an acute depressive bipolar episode in real-life French population.
time frame: 12 months
measure: Description of the management patterns (such as number and drug-class of treatments, number and type of resource used) associated with the presence and absence of sub-syndromal symptoms after an acute bipolar depressive episode.
time frame: 12 months
arm group label: Bipolar disorder patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: J M AZORIN, Professor
role: Principal Investigator
affiliation: Hopital Sainte Marguerite - MARSEILLE - FRANCE
last name: A SOLVET, Doctor
role: Study Director
affiliation: AstraZeneca - FRANCE
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country: France
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=929&filename=NIS-NFR-XXX-2012-1_Clinical_Study_Report_Synopsis.pdf
description: NIS-NFR-XXX-2012-1_Clinical_Study_Report_Synopsis.pdf
responsible party type: Sponsor
mesh term: Bipolar Disorder