Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06665984

Conditions

Pediatric Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT06665984

Start date

Dec 6, 2022

Status verified date

Feb, 2026

Completion date

Dec 6, 2046

Anticipated

Primary completion date

Dec 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Bipolar Patients

Offspring of Bipolar Parents

Healthy Control Subjects

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jair C Soares, M.D. PhD

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

Courtney Vecera

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77479

Contacts

Jair C Soares, M.D. PhD

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

Courtney Vecera

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-02-18.