Pediatric Bipolar DisorderGHAPBRNCT06665984
Greater Houston Area Pediatric Bipolar Registry
An observational study of Pediatric Bipolar Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Bipolar Disorder
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2022to 6 Dec 2046
- How long will I take part?
- 19 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects will be recruited from the Harris County Psychiatric Center, Harris Center for Mental Health, Texana Behavioral Healthcare Clinic, and UT Child and Adolescent Outpatient Psychiatry Clinic at Behavioral Science Campus, community referrals, referrals from other health providers, as well as self-referrals.
Who may be able to join
None listed.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77479
Jair C Soares, M.D. PhD, (713) 486-6663, utmooddisorders@uth.tmc.edu
Courtney Vecera, (713) 486-6663, utmooddisorders@uth.tmc.edu
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Patients | Not described | |
| Offspring of Bipolar Parents | Not described | |
| Healthy Control Subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Identification of Bipolar Disorder as Assessed by Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid 7.2) (child)
Measured: baseline, annually until participant turns 25 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start6 Dec 2022
- Primary completion6 Dec 2027 (estimated)
- Study completion6 Dec 2046 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 19 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- John S. Dunn Foundation
- Responsible party
- Principal investigator, Jair Soares, The University of Texas Health Science Center, Houston
- Investigators
- Jair C Soares, M.D. PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665984
- Sponsor's protocol ID
- HSC-MS-20-0329
- Acronym
- GHAPBR
- Status last verified
- Feb 2026
- First submitted
- 4 Aug 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Greater Houston Area Pediatric Bipolar Registry
- ClinicalTrials.gov ID
- NCT06665984
- Acronym / sponsor ID
- GHAPBR / HSC-MS-20-0329
- Conditions
- Pediatric Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- John S. Dunn Foundation
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 6 Dec 2027 (estimated)
- Study completion
- 6 Dec 2046 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 19 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bipolar Patients | – | – |
| Offspring of Bipolar Parents | – | – |
| Healthy Control Subjects | – | – |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects will be recruited from the Harris County Psychiatric Center, Harris Center for Mental Health, Texana Behavioral Healthcare Clinic, and UT Child and Adolescent Outpatient Psychiatry Clinic at Behavioral Science Campus, community referrals, referrals from other health providers, as well as self-referrals.
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jair C Soares, M.D. PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Bipolar Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jair C Soares, M.D. PhD ((713) 486-6663, utmooddisorders@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.