NCT06665984 · The University of Texas Health Science Center, Houston
Greater Houston Area Pediatric Bipolar Registry
(GHAPBR)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2026 · Source of record for eligibility and locations