Greater Houston Area Pediatric Bipolar Registry

NCT06665984 | Recruiting

• 1 other identifier: HSC-MS-20-0329
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Bipolar Patients

Offspring of Bipolar Parents

Healthy Control Subjects

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the Harris County Psychiatric Center, Harris Center for Mental Health, Texana Behavioral Healthcare Clinic, and UT Child and Adolescent Outpatient Psychiatry Clinic at Behavioral Science Campus, community referrals, referrals from other health providers, as well as self-referrals.

You may qualify if:

• 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

You may not qualify if:

• 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
• Any Psychiatric Diagnosis
• Any family history of Bipolar Disorder, Psychotic Disorder, Schizophrenia, or Schizoaffective disorder in a first-degree relative
• Any family history of a neurological condition in a first-degree relative.
• Mental Retardation/Intellectual Disability
• Severe Neurological Disorder that affects cognitive status (e.g., epilepsy, traumatic brain injury, tubular sclerosis)
• Schizophrenia
• Uncontrolled or severe medical problem per investigator judgement
• Autism Spectrum Disorders (ASD)
• Intellectual Developmental Disorder

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• John S. Dunn Foundation: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77479, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Approximately 2ml of Saliva will be collected and processed for DNA. Blood will be collected and plasma and peripheral blood mononuclear cells (PBMCs) will be isolated

Study Officials

• Jair C Soares, M.D. PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jair C Soares, M.D. PhD

CONTACT

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

Courtney Vecera

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 19 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: October 30, 2024
• Study Start: December 6, 2022
• Primary Completion (Estimated): December 6, 2027
• Study Completion (Estimated): December 6, 2046
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)