<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/NCT01678989</url>
  </required_header>
  <id_info>
    <org_study_id>4946498</org_study_id>
    <nct_id>NCT01678989</nct_id>
  </id_info>
  <brief_title>Evaluation of Brain MRI and Clinical Characteristics of Adolescents With Bipolar Disorder and Children of Parents With Bipolar Disorder</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turkish Psychiatry Association</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Turkish Psychiatry Association</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Genetic transition is important in the etiology of bipolar disorder (BD). So, evaluation of&#xD;
      children of BD parents and diagnosed with and BD children whether or not brain has affected&#xD;
      zones. These groups were compared to healthy controls and whether or not the mental health of&#xD;
      children is influenced will be evaluated by the clinical investigation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MRI studies in children at risk of BD, our understanding of the neurobiology of BD and&#xD;
      abnormalities in the studied regions, regions that predispose to the development of our&#xD;
      understanding of PBB will shed light on the etiology of the disorder. In this study, the&#xD;
      cranial MRI findings and clinical features in adolescents with bipolar disorder and the same&#xD;
      age and sex matched children who have parents with BD and healthy controls were investigated.&#xD;
      Since there is few studies that evaluate these three groups, there is a need to increase our&#xD;
      knowledge on this issue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2011</start_date>
  <completion_date type="Anticipated">June 2013</completion_date>
  <primary_completion_date type="Anticipated">June 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Patient group</arm_group_label>
    <description>Children with BD, (20 children) 12-18 year-old who agreed to participate in the study will be established.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Risk group</arm_group_label>
    <description>Twenty healthy children of 12-18 years old who have mothers and/or fathers who previously assessed by an adult psychiatrist and diagnosed as BD according to DSM-IV diagnostic criteria, and who agreed to participate in the study. The age and gender of the groups will be matched.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control group</arm_group_label>
    <description>Twenty participants between the ages of 12-18 who agree to participate in the study and whose family members do not have BD. The age and the gender of the groups will be matched.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        In this study, the cranial MRI findings and clinical features in adolescents with bipolar&#xD;
        disorder and the same age and sex matched children who have parents with BD and healthy&#xD;
        controls were investigated.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with BD between the ages of 12-18&#xD;
&#xD;
          -  Parents with BD who have children between the ages of 12-18&#xD;
&#xD;
          -  Healthy children whose parents do not have BD&#xD;
&#xD;
          -  Patients who does not have mental or organic disability to answer the questions&#xD;
&#xD;
          -  Graduated from primary school&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have mental or organic disability to answer the questions&#xD;
&#xD;
          -  Patients who have a history of any chronic disease which is likely to affect the&#xD;
             central nervous system&#xD;
&#xD;
          -  Patients who have a contraindication for any first application for Magnetic Resonance&#xD;
             Imaging (MRI)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Seher Akbas</last_name>
    <phone>09003623121919</phone>
    <phone_ext>3128</phone_ext>
    <email>akbasseher@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gökhan Sarisoy</last_name>
    <phone>09003623121910</phone>
    <phone_ext>3777</phone_ext>
    <email>gokhansarisoy@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ondokuz Mayis University Medical Faculty Department of Child and Adolescent Psychiatry</name>
      <address>
        <city>Samsun</city>
        <zip>55139</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seher Akbas</last_name>
      <phone>00903623121919</phone>
      <phone_ext>3128</phone_ext>
      <email>akbasseher@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Seher Akbas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>September 4, 2012</last_update_submitted>
  <last_update_submitted_qc>September 4, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Turkish Psychiatry Association</investigator_affiliation>
    <investigator_full_name>Seher Akbas</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Bipolar disorder</keyword>
  <keyword>Children</keyword>
  <keyword>Cranial MRI</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/NCT01678989
org study id: 4946498
nct id: NCT01678989
lead sponsor: 
has dmc: No
Genetic transition is important in the etiology of bipolar disorder (BD). So, evaluation of
      children of BD parents and diagnosed with and BD children whether or not brain has affected
      zones. These groups were compared to healthy controls and whether or not the mental health of
      children is influenced will be evaluated by the clinical investigation.
MRI studies in children at risk of BD, our understanding of the neurobiology of BD and
      abnormalities in the studied regions, regions that predispose to the development of our
      understanding of PBB will shed light on the etiology of the disorder. In this study, the
      cranial MRI findings and clinical features in adolescents with bipolar disorder and the same
      age and sex matched children who have parents with BD and healthy controls were investigated.
      Since there is few studies that evaluate these three groups, there is a need to increase our
      knowledge on this issue.
time perspective: Prospective
arm group label: Patient group
description: Children with BD, (20 children) 12-18 year-old who agreed to participate in the study will be established.
arm group label: Risk group
description: Twenty healthy children of 12-18 years old who have mothers and/or fathers who previously assessed by an adult psychiatrist and diagnosed as BD according to DSM-IV diagnostic criteria, and who agreed to participate in the study. The age and gender of the groups will be matched.
arm group label: Healthy control group
description: Twenty participants between the ages of 12-18 who agree to participate in the study and whose family members do not have BD. The age and the gender of the groups will be matched.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Seher Akbas
phone: 09003623121919
phone ext: 3128
email: akbasseher@hotmail.com
last name: Gökhan Sarisoy
phone: 09003623121910
phone ext: 3777
email: gokhansarisoy@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Turkish Psychiatry Association
investigator full name: Seher Akbas
investigator title: Associate Professor
mesh term: Bipolar Disorder