Registry for pediatric bipolar disorder in the Greater Houston Area

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.