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

• ClinicalTrials.gov Identifier: NCT01678989
• Recruitment Status: Unknown
• First Posted: September 5, 2012
• Last Update Posted: September 5, 2012
• Sponsor: Turkish Psychiatry Association
• 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

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

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