Registry for pediatric bipolar disorder in the Greater Houston Area
Greater Houston Area Pediatric Bipolar Registry
This study is looking at children and teens with bipolar disorder, their siblings, and healthy kids to see how their genes and brain structures relate to mood changes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06665984 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess children and adolescents diagnosed with bipolar disorder, those who are offspring of parents with bipolar disorder, and healthy controls. Participants will provide blood and saliva samples for the evaluation of biomarkers and genetic information related to bipolar disorder. Additionally, the study will utilize MRI techniques to investigate brain structures and pathways linked to mood regulation and the progression of bipolar disorder. The research also aims to inform participants about future studies they may qualify for and recommend follow-up care if necessary.
Who should consider this trial
Good fit: Ideal candidates include children and adolescents meeting DSM-V criteria for bipolar disorder, offspring of parents with bipolar disorder, and healthy controls.
Not a fit: Patients with autism spectrum disorder, severe neurological disorders, or significant medical problems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and early identification of pediatric bipolar disorder, potentially improving treatment outcomes.
How similar studies have performed: While there have been studies on pediatric bipolar disorder, this registry approach focusing on biomarkers and MRI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Jair C Soares, M.D. PhD — The University of Texas Health Science Center, Houston
- Study coordinator: Jair C Soares, M.D. PhD
- Email: utmooddisorders@uth.tmc.edu
- Phone: (713) 486-6663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.