- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01678989
Evaluation of Brain MRI and Clinical Characteristics of Adolescents With Bipolar Disorder and Children of Parents With Bipolar Disorder
September 4, 2012 updated by: Seher Akbas, Turkish Psychiatry Association
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.
Study Overview
Status
Unknown
Conditions
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
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Samsun, Turkey, 55139
- Recruiting
- Ondokuz Mayis University Medical Faculty Department of Child and Adolescent Psychiatry
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Contact:
- Seher Akbas
- Phone Number: 3128 00903623121919
- Email: akbasseher@hotmail.com
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Principal Investigator:
- Seher Akbas
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patient group
Children with BD, (20 children) 12-18 year-old who agreed to participate in the study will be established.
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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.
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Anticipated)
June 1, 2013
Study Completion (Anticipated)
June 1, 2013
Study Registration Dates
First Submitted
August 31, 2012
First Submitted That Met QC Criteria
September 4, 2012
First Posted (Estimate)
September 5, 2012
Study Record Updates
Last Update Posted (Estimate)
September 5, 2012
Last Update Submitted That Met QC Criteria
September 4, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4946498
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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