Greater Houston Area Pediatric Bipolar Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06665984

Acronym

GHAPBR

Enrollment

1000

Registered

2024-10-30

Start date

2022-12-06

Completion date

2046-12-06

Last updated

2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Bipolar Disorder

Brief summary

The purpose of this study is to perform a comprehensive research assessment of children and adolescents who meet The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for Bipolar Disorder (BD) , offspring of a parent with BD, and healthy controls (HC), to obtain blood samples and saliva samples from each subject to allow the evaluation for BD biomarkers and genetic information, to notify participants about future research studies they may qualify for , to recommend follow-up with an outpatient provider if needed and to use magnetic resonance imaging (MRI) (structural MRI and diffusion tensor imaging) to investigate brain structures and relevant pathways associated with mood and behavioral regulation, conversion from softer forms of the BD spectrum (BD-NOS) to harder forms (BD-I and BD-II) and possible early identification.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

for bipolar patients or offspring of bipolar parents: * Any current mood state (in the case of bipolar subjects) * For bipolar patients: DSM-V criteria for BD type I, BD type II, or BD NOS, as per the administration of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) * For the offspring of bipolar parents: at least one parent meeting DSM-V criteria for BD type I or BD type II, or BD NOS as per the administration of the MINI Adult

Exclusion criteria

for bipolar patients or offspring of bipolar parents: * Autism Spectrum Disorder (ASD) * Developmental Intellectual Disorder * Severe Neurological Disorder that affects cognitive status (e.g., epilepsy, traumatic brain injury, tubular sclerosis) * Schizophrenia * Uncontrolled or severe medical problem per investigator judgment * For the offspring: parents with a history of any brain diseases, including seizures, stroke, meningitis, encephalitis, dementia, and other degenerative brain diseases; parents with a history of intellectual disability

Design outcomes

Primary

Measure	Time frame
Positive Identification of Bipolar Disorder as Assessed by Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid 7.2) (child)	baseline, annually until participant turns 25 years of age

Countries

United States

Contacts

CONTACTJair C Soares, M.D. PhD

utmooddisorders@uth.tmc.edu(713) 486-6663

CONTACTCourtney Vecera