NCT01678989

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 5, 2012

Status Verified

August 1, 2012

Enrollment Period

1.9 years

First QC Date

August 31, 2012

Last Update Submit

September 4, 2012

Conditions

Keywords

Bipolar disorderChildrenCranial MRI

Study Arms (3)

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.

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University Medical Faculty Department of Child and Adolescent Psychiatry

Samsun, 55139, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 5, 2012

Study Start

July 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 5, 2012

Record last verified: 2012-08

Locations