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NCT Number: NCT06665984

Greater Houston Area Pediatric Bipolar Registry

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.

Recruiting

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Positive Identification of Bipolar Disorder as Assessed by Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid 7.2) (child)

    Time frame: baseline, annually until participant turns 25 years of age

Study contacts

Contact information is provided by the study sponsor or research team.

Courtney Vecera

CONTACT

[email protected]

(713) 486-6663

Jair C Soares, M.D. PhD

CONTACT

[email protected]

(713) 486-6663

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • John S. Dunn Foundation

Registry information

Acronym: GHAPBR

Important dates

Study start
2022
Primary completion
2027
Study completion
2046
First posted
Oct 30, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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