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Evaluation of Brain MRI and Clinical Characteristics of Adolescents With Bipolar Disorder and Children of Parents With Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT01678989
Recruitment Status : Unknown
Verified August 2012 by Seher Akbas, Turkish Psychiatry Association.
Recruitment status was:  Recruiting
First Posted : September 5, 2012
Last Update Posted : September 5, 2012
Sponsor:
Information provided by (Responsible Party):
Seher Akbas, Turkish Psychiatry Association

Tracking Information
First Submitted Date August 31, 2012
First Posted Date September 5, 2012
Last Update Posted Date September 5, 2012
Study Start Date July 2011
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Brain MRI and Clinical Characteristics of Adolescents With Bipolar Disorder and Children of Parents With Bipolar Disorder
Official Title Not Provided
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition Bipolar Disorder
Intervention Not Provided
Study Groups/Cohorts
  • Patient group
    Children with BD, (20 children) 12-18 year-old who agreed to participate in the study will be established.
  • Risk group
    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.
  • Healthy control group
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September¬†4,¬†2012)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2013
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Children with BD between the ages of 12-18
  • Parents with BD who have children between the ages of 12-18
  • Healthy children whose parents do not have BD
  • Patients who does not have mental or organic disability to answer the questions
  • Graduated from primary school

Exclusion Criteria:

  • Patients who have mental or organic disability to answer the questions
  • Patients who have a history of any chronic disease which is likely to affect the central nervous system
  • Patients who have a contraindication for any first application for Magnetic Resonance Imaging (MRI)
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT01678989
Other Study ID Numbers 4946498
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Seher Akbas, Turkish Psychiatry Association
Study Sponsor Turkish Psychiatry Association
Collaborators Not Provided
Investigators Not Provided
PRS Account Turkish Psychiatry Association
Verification Date August 2012