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Greater Houston Area Pediatric Bipolar Registry

NCT ID: NCT06665984

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-06

Study Completion Date

2046-12-06

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Bipolar Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Bipolar Patients

No interventions assigned to this group

Offspring of Bipolar Parents

No interventions assigned to this group

Healthy Control Subjects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
* Severe Neurological Disorder that affects cognitive status (e.g., epilepsy, traumatic brain injury, tubular sclerosis)
* Schizophrenia
* Uncontrolled or severe medical problem per investigator judgement
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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John S. Dunn Foundation

UNKNOWN

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Jair Soares

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jair C Soares, M.D. PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jair C Soares, M.D. PhD

Role: CONTACT

Phone: (713) 486-6663

Email: [email protected]

Courtney Vecera

Role: CONTACT

Phone: (713) 486-6663

Email: [email protected]

Facility Contacts

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Jair C Soares, M.D. PhD

Role: primary

Courtney Vecera

Role: backup

Other Identifiers

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HSC-MS-20-0329

Identifier Type: -

Identifier Source: org_study_id