<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/NCT02988518</url>
  </required_header>
  <id_info>
    <org_study_id>UF 9418</org_study_id>
    <secondary_id>2014-A00825-42</secondary_id>
    <nct_id>NCT02988518</nct_id>
  </id_info>
  <brief_title>Cognitive Remediation on Patients With Bipolar Disorder and Memory Complaints</brief_title>
  <acronym>COGMED</acronym>
  <official_title>Evaluation of a Cognitive Remediation Program on Patients With Bipolar Disorders, With Memory Complaints</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bipolar disorder is a major health concern. Intercritical periods are marked with residual&#xD;
      symptoms, both thymic and cognitive, which affects quality of life of patients, but also the&#xD;
      quality of observance. The implementation of cognitive remediation programs could be&#xD;
      interesting. The aim of this study is to evaluate the overall performance on euthymic bipolar&#xD;
      patients with memory complaints included in the program named &quot;COGMED&quot;, targeting the working&#xD;
      memory.&#xD;
&#xD;
      The impact of this program on compliance, quality of life, and memory complaints will be&#xD;
      evaluated.&#xD;
&#xD;
      The investigator will measure whether there is a correlation between working memory and&#xD;
      overall performances.&#xD;
&#xD;
      Finally, the investigator will try to achieve a profile of bipolar patients in whom the&#xD;
      Cogmed program is particularly effective on a plan of overall performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with bipolar disorder and memory complaints will be recruited.&#xD;
&#xD;
      Two visits :&#xD;
&#xD;
        1. at baseline (V0) : the investigator evaluate bipolar disorder, treatment, mood, quality&#xD;
           of life, global functioning, and memory complaints. Patients also have a&#xD;
           neuropsychological assessment. The COGMED program is proposed to patients with memory&#xD;
           complaints and explain by the investigator&#xD;
&#xD;
        2. 4-6 weeks after the end of the program (11-13 weeks after V1) : the same evaluation is&#xD;
           realized to compare score before and after the program of cognitive remediation.&#xD;
&#xD;
      Between the two visits the patient will benefit of COGMED program, at home, during 5 weeks.&#xD;
&#xD;
      COGMED is a remediation cognitive program, based on working memory, consisting on daily&#xD;
      exercises at home on a computer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of the global functioning between the inclusion and the end of the program</measure>
    <time_frame>At 4 weeks</time_frame>
    <description>evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evolution of the global functioning between the inclusion and the end of the program</measure>
    <time_frame>At 6 weeks</time_frame>
    <description>evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Observance</measure>
    <time_frame>At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)</time_frame>
    <description>Evaluation of variation of patient's compliance by Medication Adherence Rating Scale (MARS) score after COGMED program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)</time_frame>
    <description>Evaluation of variation of quality of life by Short Form (36) Health Survey (SF-36) score after COGMED program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between working memory and global functioning</measure>
    <time_frame>At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)</time_frame>
    <description>Searching a statistical correlation between global functioning (using FAST) and working memory (using neuropsychological tests)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Memory complaints</measure>
    <time_frame>At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)</time_frame>
    <description>Variations on memory complaints will be evaluated by Mac Nair Scale score before and after COGMED program.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">41</enrollment>
  <condition>Patient With Bipolar Disorder</condition>
  <condition>Euthymic Status</condition>
  <condition>Wirh Memory Complaints</condition>
  <arm_group>
    <arm_group_label>COGMED program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive remediation using COGMED program on bipolar euthymic patients with memory complaints</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>COGMED program</intervention_name>
    <description>Patient should connect on his computer at home, 5 times a week, for 5 weeks. Every day, the patient has to do 8 exercises for a total duration of 30 to 45 minutes.&#xD;
In total, the patient will have to complete 25 sessions. The difficulty level of the proposed items adjust automatically to the patient's maximum capacity to compel him to provide a cognitive effort. A progression index assesses the progress made by the patient.&#xD;
Every week, the investigator will call the patient for 10 minutes in order to gather the patient's feelings, his difficulties, provide some advice and encourage him.&#xD;
The investigator will have to analyze the results of curves available for each event, as well as the patient's progress index.</description>
    <arm_group_label>COGMED program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Being diagnosed bipolar according to the Diagnostic and Statistical Manual of Mental&#xD;
             Disorders - IV (DSM-IV) criteria&#xD;
&#xD;
          -  Memory complaints or overall performance alterations according to the memory scale&#xD;
             (MEM III Wechsler memory scale - third edition)&#xD;
&#xD;
          -  Being euthymic at the inclusion according to Montgomery-Asberg Depression Rating Scale&#xD;
             (MADRS &lt; 12) and Young Mania Rating Scale (YMRS &lt; 6)&#xD;
&#xD;
          -  Not being treated with electroconvulsive therapy for the last year&#xD;
&#xD;
          -  Not having drug-dependance or drug-abuse for the last six months&#xD;
&#xD;
          -  Having a computer with internet and a cellphone at home&#xD;
&#xD;
          -  Having signed informed consent&#xD;
&#xD;
          -  Able to understand nature, aims and methodology of the study&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patient on protective measures (guardianship or trusteeship)&#xD;
&#xD;
          -  Deprived of liberty subject (judicial or administrative decision)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Emilie OLIE, MD PhD</last_name>
    <phone>+33 4 67 33 85 81</phone>
    <email>e-olie@chu-montpellier.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Montpellier University Hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine GENTY, MD</last_name>
      <phone>+33 4 67 99 61 45 75</phone>
      <email>c-genty@chu-montpellier.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psychiatry</keyword>
  <keyword>Bipolar disorder</keyword>
  <keyword>Memory complaints</keyword>
  <keyword>Global functioning</keyword>
  <keyword>Cognitive remediation</keyword>
  <keyword>Working memory</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_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/NCT02988518
org study id: UF 9418
secondary id: 2014-A00825-42
nct id: NCT02988518
lead sponsor: 
has dmc: No
Bipolar disorder is a major health concern. Intercritical periods are marked with residual
      symptoms, both thymic and cognitive, which affects quality of life of patients, but also the
      quality of observance. The implementation of cognitive remediation programs could be
      interesting. The aim of this study is to evaluate the overall performance on euthymic bipolar
      patients with memory complaints included in the program named "COGMED", targeting the working
      memory.

      The impact of this program on compliance, quality of life, and memory complaints will be
      evaluated.

      The investigator will measure whether there is a correlation between working memory and
      overall performances.

      Finally, the investigator will try to achieve a profile of bipolar patients in whom the
      Cogmed program is particularly effective on a plan of overall performance.
Patients with bipolar disorder and memory complaints will be recruited.

      Two visits :

        1. at baseline (V0) : the investigator evaluate bipolar disorder, treatment, mood, quality
           of life, global functioning, and memory complaints. Patients also have a
           neuropsychological assessment. The COGMED program is proposed to patients with memory
           complaints and explain by the investigator

        2. 4-6 weeks after the end of the program (11-13 weeks after V1) : the same evaluation is
           realized to compare score before and after the program of cognitive remediation.

      Between the two visits the patient will benefit of COGMED program, at home, during 5 weeks.

      COGMED is a remediation cognitive program, based on working memory, consisting on daily
      exercises at home on a computer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Evolution of the global functioning between the inclusion and the end of the program
time frame: At 4 weeks
description: evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program.
measure: Evolution of the global functioning between the inclusion and the end of the program
time frame: At 6 weeks
description: evaluation of variation of global functioning will be realized by the Functioning Assessment Short Test (FAST) scale after COGMED program
measure: Observance
time frame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
description: Evaluation of variation of patient's compliance by Medication Adherence Rating Scale (MARS) score after COGMED program.
measure: Quality of life
time frame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
description: Evaluation of variation of quality of life by Short Form (36) Health Survey (SF-36) score after COGMED program.
measure: Correlation between working memory and global functioning
time frame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
description: Searching a statistical correlation between global functioning (using FAST) and working memory (using neuropsychological tests)
measure: Memory complaints
time frame: At the inclusion and 4 to 6 weeks until the end of the program COGMED (11 to 13 weeks after inclusion)
description: Variations on memory complaints will be evaluated by Mac Nair Scale score before and after COGMED program.
arm group label: COGMED program
arm group type: Experimental
description: Cognitive remediation using COGMED program on bipolar euthymic patients with memory complaints
intervention type: Behavioral
intervention name: COGMED program
description: Patient should connect on his computer at home, 5 times a week, for 5 weeks. Every day, the patient has to do 8 exercises for a total duration of 30 to 45 minutes.
In total, the patient will have to complete 25 sessions. The difficulty level of the proposed items adjust automatically to the patient's maximum capacity to compel him to provide a cognitive effort. A progression index assesses the progress made by the patient.
Every week, the investigator will call the patient for 10 minutes in order to gather the patient's feelings, his difficulties, provide some advice and encourage him.
The investigator will have to analyze the results of curves available for each event, as well as the patient's progress index.
arm group label: COGMED program
criteria: 
gender: All
minimum age: 18 Months
maximum age: 65 Years
healthy volunteers: No
last name: Emilie OLIE, MD PhD
phone: +33 4 67 33 85 81
email: e-olie@chu-montpellier.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Bipolar Disorder
sharing ipd: No