Greater Houston Area Pediatric Bipolar Registry (GHAPBR)

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Bipolar Disorder

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Jair C Soares, M.D. PhD; Phone Number: (713) 486-6663; Email: utmooddisorders@uth.tmc.edu
• Study Contact Backup: Name: Courtney Vecera; Phone Number: (713) 486-6663; Email: utmooddisorders@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77479
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Jair C Soares, M.D. PhD; Phone Number: (713) 486-6663; Email: utmooddisorders@uth.tmc.edu
      • Contact: Courtney Vecera; Phone Number: (713) 486-6663; Email: utmooddisorders@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Exclusion Criteria for healthy control subjects:

• 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

Exclusion criteria for annual visits:

• Autism Spectrum Disorders (ASD)
• Intellectual Developmental Disorder
• Severe Neurological Disorder that affects cognitive status (e.g., epilepsy, traumatic brain injury, tubular sclerosis)
• Schizophrenia
• Uncontrolled or severe medical problem per investigator judgement

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy Control Subjects
Bipolar Patients
Offspring of Bipolar Parents

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: John S. Dunn Foundation
• Investigators: Principal Investigator: Jair C Soares, M.D. PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Estimated): December 6, 2027
• Study Completion (Estimated): December 6, 2046

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Mood Disorders; Bipolar Disorder
• Other Study ID Numbers: HSC-MS-20-0329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No