Greater Houston Area Pediatric Bipolar Registry

Обзор

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.

Первичные конечные точки

• Positive Identification of Bipolar Disorder as Assessed by Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid 7.2) (child) [Срок оценки: baseline, annually until participant turns 25 years of age]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT06665984 · HSC-MS-20-0329

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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