<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/NCT03295305</url>
  </required_header>
  <id_info>
    <org_study_id>H-16043480</org_study_id>
    <secondary_id>2012-58-0004</secondary_id>
    <nct_id>NCT03295305</nct_id>
  </id_info>
  <brief_title>Effect of Action-Based Cognitive Remediation in Patients With Bipolar Disorder</brief_title>
  <acronym>PRETEC-ABC</acronym>
  <official_title>Effect of Action-Based Cognitive Remediation on Cognition and Frontal Lobe Activity in Patients With Bipolar Disorder in Remission (PRETEC-ABC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mental Health Services in the Capital Region, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lundbeck Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mental Health Services in the Capital Region, Denmark</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>
      PRETEC-ABC aims to assess the effect of a new form of cognitive remediation, Action-Based&#xD;
      Cognitive Remediation (ABCR), in patients with bipolar disorder in remission on cognition,&#xD;
      and to assess the neural assays for treatment effects with the purpose of identifying a&#xD;
      neural biomarker for pro-cognitive effect. It is hypothesized (i) that ABCR vs. a control&#xD;
      treatment has a beneficial effect on cognition in remitted patients with bipolar disorder&#xD;
      remission. It is hypothesized (ii) that this treatment-associated improvement of cognition&#xD;
      translates into better functional capacity at a six months follow-up assessment (secondary&#xD;
      outcome). Finally, as an exploratory measure, it is hypothesized that ABCR will produce an&#xD;
      early change in frontal activity and that this activity will correlate with ABCR-associated&#xD;
      improvements in cognitive function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial will include outpatients with BD in full or partial remission (a score ≤14 on the&#xD;
      Hamilton Depression Rating Scale (HDRS) and Young Mania Rating Scale (YMRS). Recruitment will&#xD;
      be carried out through the ongoing Bipolar Illness Onset (BIO) study, the Copenhagen&#xD;
      Affective Disorder Clinic, Psychiatric Centre Copenhagen, Rigshospitalet, other mental health&#xD;
      centres, consultant psychiatrists in the Capital Region of Denmark, and through&#xD;
      advertisements on relevant websites.&#xD;
&#xD;
      Participants will undergo an eligibility assessment followed by randomisation. When 4 - 6&#xD;
      participants have been randomised to either the ABCR or the control group, the baseline&#xD;
      assessments are carried out. The baseline assessment is completed over two days, 1 - 3 days&#xD;
      apart. A fMRI scan is carried out on day 1 encompassing spatial and verbal working memory&#xD;
      N-back tasks, a picture encoding task, a resting state and a structural scan. On day 2, a&#xD;
      blood sample is drawn in the morning, followed by administration of a comprehensive&#xD;
      neuropsychological test battery. Participants fill in questionnaires concerning subjective&#xD;
      cognitive complaints, psychosocial functioning and quality of life and functional capacity is&#xD;
      assessed using a clinician-rated interview and a performance based assessment. Sleep quantity&#xD;
      and quality in the past three days is assessed. After two weeks of ABCR or control treatment,&#xD;
      functional MRI, neuropsychological testing an assessment of mood and subjective cognition are&#xD;
      repeated. These assessments, as well as assessments of functional capacity and quality of&#xD;
      life, are repeated within two weeks after treatment completion and six months after treatment&#xD;
      completion.&#xD;
&#xD;
      Block randomisation is carried out by Pharma Consulting Group, stratified by gender and age&#xD;
      (patients &lt; or ≥ 35 years).&#xD;
&#xD;
      Power calculation was also carried out by Pharma Consulting Group based on findings from a&#xD;
      previous RCT in our group assessing the effect of 8 weeks of EPO treatment on the same&#xD;
      cognitive composite score. In PreTEC-ABC, a clinically relevant difference between the ABCR&#xD;
      and the control groups following 10 weeks of treatment is assumed to be 0.4 SD (corresponding&#xD;
      to a medium effect size) on the primary outcome, with a mean change in the cognitive&#xD;
      composite score of 0.5 SD. Assuming a 10% drop-out rate, we will recruit up to N=58 in order&#xD;
      to achieve complete datasets for N=52 participants.&#xD;
&#xD;
      Data will be analysed using mixed models using intention-to-treat (ITT) analyses.&#xD;
&#xD;
      Functional MRI-data will be pre-processed and analysed with the FMRIB Expert Analysis Tool&#xD;
      (FEAT) and the &quot;randomize&quot; algorithm implemented in FMRIB Software Library (FSL). Functional&#xD;
      MRI data will be analysed using a Region of interest (ROI) analysis to assess differences&#xD;
      between the ABCR and control group in neural activity in the dlPFC and the hippocampi after 2&#xD;
      weeks. Exploratory whole-brain analyses will be conducted to investigate any effects in other&#xD;
      brain regions. Any differences in neural activity will be correlated with potential changes&#xD;
      in the cognitive composite score at weeks 2 and post-treatment. If there is a significant&#xD;
      correlation with cognition at post-treatment, multiple regression analysis will be carried&#xD;
      out, adjusting for mood and demographic characteristics, to assess whether early change in&#xD;
      neural activity is predictive of pro-cognitive effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">January 25, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive composite score</measure>
    <time_frame>Change from baseline and week 11</time_frame>
    <description>A cognitive composite based on an average of the Rey Auditory Verbal Learning Test (RAVLT), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding, verbal fluency with the letter &quot;D&quot;, WAIS-III Letter-Number Sequencing, Trail Making Test B (TMT B) and Rapid Visual Information Processing (RVP) from Cambridge Cognition (CANTAB).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>One Touch Stockings of Cambridge</measure>
    <time_frame>Baseline, two weeks of treatment, week 11, and 6-months follow-up</time_frame>
    <description>A computerized neuropsychological test assessing executive functions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment Short Test</measure>
    <time_frame>Baseline, week 11, and 6-months follow-up</time_frame>
    <description>A semi-structured interview assessing level of functioning</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rey Auditory Verbal Learning Test</measure>
    <time_frame>Baseline, two weeks of treatment, week 11, and 6-months follow-up</time_frame>
    <description>Neuropsychological test assessing verbal memory</description>
  </other_outcome>
  <other_outcome>
    <measure>Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding</measure>
    <time_frame>Baseline, two weeks of treatment, week 11, and 6-months follow-up</time_frame>
    <description>Neuropsychological test assessing attention</description>
  </other_outcome>
  <other_outcome>
    <measure>Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Digit Span</measure>
    <time_frame>Baseline, two weeks of treatment, week 11, and 6-months follow-up</time_frame>
    <description>Neuropsychological test assessing executive functions</description>
  </other_outcome>
  <other_outcome>
    <measure>Verbal fluency with the letter &quot;D&quot; and 'S&quot;</measure>
    <time_frame>Baseline, two weeks of treatment, week 11, and 6-months follow-up</time_frame>
    <description>Neuropsychological test assessing executive functions</description>
  </other_outcome>
  <other_outcome>
    <measure>WAIS-III Letter-Number Sequencing</measure>
    <time_frame>Baseline, two weeks of treatment, week 11, and 6-months follow-up</time_frame>
    <description>Neuropsychological test assessing executive functions</description>
  </other_outcome>
  <other_outcome>
    <measure>Trail Making Test B</measure>
    <time_frame>Baseline, two weeks of treatment, week 11, and 6-months follow-up</time_frame>
    <description>Neuropsychological test assessing psychomotor speed</description>
  </other_outcome>
  <other_outcome>
    <measure>Trail Making Test A</measure>
    <time_frame>Baseline, two weeks of treatment, week 11, and 6-months follow-up</time_frame>
    <description>Neuropsychological test assessing executive functions</description>
  </other_outcome>
  <other_outcome>
    <measure>Rapid Visual Information Processing (RVP) from Cambridge Cognition (CANTAB)</measure>
    <time_frame>Baseline, two weeks of treatment, week 11, and 6-months follow-up</time_frame>
    <description>Neuropsychological test assessing sustained attention</description>
  </other_outcome>
  <other_outcome>
    <measure>Spatial Working Memory (SWM) from Cambridge Cognition</measure>
    <time_frame>Baseline, two weeks of treatment, week 11, and 6-months follow-up</time_frame>
    <description>Neuropsychological test assessing sustained attention</description>
  </other_outcome>
  <other_outcome>
    <measure>Brief University of California, San Diego Performance-Based Skills Assessment-B (UPSA-B)</measure>
    <time_frame>Baseline, week 11, and 6-months follow-up</time_frame>
    <description>Objective assessment of level of functioning</description>
  </other_outcome>
  <other_outcome>
    <measure>Sheehan Disability Scale</measure>
    <time_frame>Baseline, week 11, and 6-months follow-up</time_frame>
    <description>Questionnaire on level of functioning</description>
  </other_outcome>
  <other_outcome>
    <measure>The Assessment of Quality of Life</measure>
    <time_frame>Baseline, week 11, and 6-months follow-up</time_frame>
    <description>Questionnaire on quality of life</description>
  </other_outcome>
  <other_outcome>
    <measure>World Health Organization Quality of Life (WHOQOL-BREF)</measure>
    <time_frame>Baseline, week 11, and 6-months follow-up</time_frame>
    <description>Questionnaire on quality of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA)</measure>
    <time_frame>Baseline, two weeks of treatment, week 11,and 6-months follow-up</time_frame>
    <description>Questionnaire on subjective cognitive complaints</description>
  </other_outcome>
  <other_outcome>
    <measure>Work and Social Adjustment Scale (WSAS)</measure>
    <time_frame>Baseline, week 11, and 6-months follow-up</time_frame>
    <description>Questionnaire on occupational functioning</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Bipolar Disorder</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Action Based Cognitive Remediation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Unstructured support group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Action-Based Cognitive Remediation</intervention_name>
    <arm_group_label>Action Based Cognitive Remediation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Unstructured support group</intervention_name>
    <arm_group_label>Unstructured support group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fluent Danish skills and objective cognitive impairment (a total score below cutoff,&#xD;
             or scores below cutoff on a minimum of two out of the five subtests (Verbal Learning&#xD;
             Test - Immediate, Working Memory Test, Verbal Fluency Test, Verbal Learning Test -&#xD;
             Delayed and Processing Speed Test) on the Screen for Cognitive Impairment in&#xD;
             Psychiatry - Danish version (SCIP-D).&#xD;
&#xD;
          -  Patients must meet the ICD-10 diagnosis of BD (type I and II) confirmed using the&#xD;
             Schedules for Clinical Assessment in Neuropsychiatry (SCAN) interview.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Daily use of benzodiazepines &gt; 22.5 mg oxazepam, pregnancy, current drug or substance&#xD;
             abuse (three months prior to inclusion), previous serious head trauma, severe physical&#xD;
             illness, neurological illness, schizophrenia or schizoaffective disorder, dyslexia,&#xD;
             claustrophobia, having a pacemaker or other metal implants inside the body and&#xD;
             electroconvulsive therapy in the three months prior to inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kamilla W Miskowiak, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mental Health Services, Capital Region of Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mental Health Services, Capital Region of Denmark, Copenhagen University Hospital, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>March 3, 2020</last_update_submitted>
  <last_update_submitted_qc>March 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mental Health Services in the Capital Region, Denmark</investigator_affiliation>
    <investigator_full_name>Kamilla Woznica Miskowiak</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Biomarker</keyword>
  <keyword>Bipolar Disorder</keyword>
  <keyword>Cognition</keyword>
  <keyword>Cognitive Impairment</keyword>
  <keyword>cognitive remediation</keyword>
  <keyword>functional magnetic resonance imaging</keyword>
  <keyword>pro-cognitive effect</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
    <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/NCT03295305
org study id: H-16043480
secondary id: 2012-58-0004
nct id: NCT03295305
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
PRETEC-ABC aims to assess the effect of a new form of cognitive remediation, Action-Based
      Cognitive Remediation (ABCR), in patients with bipolar disorder in remission on cognition,
      and to assess the neural assays for treatment effects with the purpose of identifying a
      neural biomarker for pro-cognitive effect. It is hypothesized (i) that ABCR vs. a control
      treatment has a beneficial effect on cognition in remitted patients with bipolar disorder
      remission. It is hypothesized (ii) that this treatment-associated improvement of cognition
      translates into better functional capacity at a six months follow-up assessment (secondary
      outcome). Finally, as an exploratory measure, it is hypothesized that ABCR will produce an
      early change in frontal activity and that this activity will correlate with ABCR-associated
      improvements in cognitive function.
The trial will include outpatients with BD in full or partial remission (a score ≤14 on the
      Hamilton Depression Rating Scale (HDRS) and Young Mania Rating Scale (YMRS). Recruitment will
      be carried out through the ongoing Bipolar Illness Onset (BIO) study, the Copenhagen
      Affective Disorder Clinic, Psychiatric Centre Copenhagen, Rigshospitalet, other mental health
      centres, consultant psychiatrists in the Capital Region of Denmark, and through
      advertisements on relevant websites.

      Participants will undergo an eligibility assessment followed by randomisation. When 4 - 6
      participants have been randomised to either the ABCR or the control group, the baseline
      assessments are carried out. The baseline assessment is completed over two days, 1 - 3 days
      apart. A fMRI scan is carried out on day 1 encompassing spatial and verbal working memory
      N-back tasks, a picture encoding task, a resting state and a structural scan. On day 2, a
      blood sample is drawn in the morning, followed by administration of a comprehensive
      neuropsychological test battery. Participants fill in questionnaires concerning subjective
      cognitive complaints, psychosocial functioning and quality of life and functional capacity is
      assessed using a clinician-rated interview and a performance based assessment. Sleep quantity
      and quality in the past three days is assessed. After two weeks of ABCR or control treatment,
      functional MRI, neuropsychological testing an assessment of mood and subjective cognition are
      repeated. These assessments, as well as assessments of functional capacity and quality of
      life, are repeated within two weeks after treatment completion and six months after treatment
      completion.

      Block randomisation is carried out by Pharma Consulting Group, stratified by gender and age
      (patients < or ≥ 35 years).

      Power calculation was also carried out by Pharma Consulting Group based on findings from a
      previous RCT in our group assessing the effect of 8 weeks of EPO treatment on the same
      cognitive composite score. In PreTEC-ABC, a clinically relevant difference between the ABCR
      and the control groups following 10 weeks of treatment is assumed to be 0.4 SD (corresponding
      to a medium effect size) on the primary outcome, with a mean change in the cognitive
      composite score of 0.5 SD. Assuming a 10% drop-out rate, we will recruit up to N=58 in order
      to achieve complete datasets for N=52 participants.

      Data will be analysed using mixed models using intention-to-treat (ITT) analyses.

      Functional MRI-data will be pre-processed and analysed with the FMRIB Expert Analysis Tool
      (FEAT) and the "randomize" algorithm implemented in FMRIB Software Library (FSL). Functional
      MRI data will be analysed using a Region of interest (ROI) analysis to assess differences
      between the ABCR and control group in neural activity in the dlPFC and the hippocampi after 2
      weeks. Exploratory whole-brain analyses will be conducted to investigate any effects in other
      brain regions. Any differences in neural activity will be correlated with potential changes
      in the cognitive composite score at weeks 2 and post-treatment. If there is a significant
      correlation with cognition at post-treatment, multiple regression analysis will be carried
      out, adjusting for mood and demographic characteristics, to assess whether early change in
      neural activity is predictive of pro-cognitive effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Cognitive composite score
time frame: Change from baseline and week 11
description: A cognitive composite based on an average of the Rey Auditory Verbal Learning Test (RAVLT), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding, verbal fluency with the letter "D", WAIS-III Letter-Number Sequencing, Trail Making Test B (TMT B) and Rapid Visual Information Processing (RVP) from Cambridge Cognition (CANTAB).
measure: One Touch Stockings of Cambridge
time frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up
description: A computerized neuropsychological test assessing executive functions
measure: Functional Assessment Short Test
time frame: Baseline, week 11, and 6-months follow-up
description: A semi-structured interview assessing level of functioning
measure: Rey Auditory Verbal Learning Test
time frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up
description: Neuropsychological test assessing verbal memory
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding
time frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up
description: Neuropsychological test assessing attention
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Digit Span
time frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up
description: Neuropsychological test assessing executive functions
measure: Verbal fluency with the letter "D" and 'S"
time frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up
description: Neuropsychological test assessing executive functions
measure: WAIS-III Letter-Number Sequencing
time frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up
description: Neuropsychological test assessing executive functions
measure: Trail Making Test B
time frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up
description: Neuropsychological test assessing psychomotor speed
measure: Trail Making Test A
time frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up
description: Neuropsychological test assessing executive functions
measure: Rapid Visual Information Processing (RVP) from Cambridge Cognition (CANTAB)
time frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up
description: Neuropsychological test assessing sustained attention
measure: Spatial Working Memory (SWM) from Cambridge Cognition
time frame: Baseline, two weeks of treatment, week 11, and 6-months follow-up
description: Neuropsychological test assessing sustained attention
measure: Brief University of California, San Diego Performance-Based Skills Assessment-B (UPSA-B)
time frame: Baseline, week 11, and 6-months follow-up
description: Objective assessment of level of functioning
measure: Sheehan Disability Scale
time frame: Baseline, week 11, and 6-months follow-up
description: Questionnaire on level of functioning
measure: The Assessment of Quality of Life
time frame: Baseline, week 11, and 6-months follow-up
description: Questionnaire on quality of life
measure: World Health Organization Quality of Life (WHOQOL-BREF)
time frame: Baseline, week 11, and 6-months follow-up
description: Questionnaire on quality of life
measure: Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA)
time frame: Baseline, two weeks of treatment, week 11,and 6-months follow-up
description: Questionnaire on subjective cognitive complaints
measure: Work and Social Adjustment Scale (WSAS)
time frame: Baseline, week 11, and 6-months follow-up
description: Questionnaire on occupational functioning
arm group label: Action Based Cognitive Remediation
arm group type: Experimental
arm group label: Unstructured support group
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Action-Based Cognitive Remediation
arm group label: Action Based Cognitive Remediation
intervention type: Behavioral
intervention name: Unstructured support group
arm group label: Unstructured support group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kamilla W Miskowiak, Dr
role: Principal Investigator
affiliation: Mental Health Services, Capital Region of Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Mental Health Services in the Capital Region, Denmark
investigator full name: Kamilla Woznica Miskowiak
investigator title: Professor
mesh term: Cognitive Dysfunction
mesh term: Bipolar Disorder
sharing ipd: No