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Pediatric Bipolar Registry

Pediatric Bipolar Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02360267
Acronym
PBR
Enrollment
334
Registered
2015-02-10
Start date
2013-08-05
Completion date
2019-02-28
Last updated
2025-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Depression, Mania, Psychosis

Keywords

Bipolar Disorder, Pediatric, Offspring, Depression, Mania, Children of parents who suffer from Bipolar disorder

Brief summary

The goal of the Pediatric Bipolar Registry (PBR) is to provide a comprehensive assessment regarding the diagnosis and treatment of pediatric bipolar disorder to children and adolescents with any current mood state and/or children/adolescents who are offspring of a parent with bipolar disorder (BD) type I or II and their families.

Detailed description

Data collected will be utilized to perform a retrospective chart review to include measure outcomes and de-identified demographic information detailed in the attached case report forms. In each case where a diagnosis of bipolar disorder I, bipolar disorder II, or bipolar disorder NOS is determined, the child/adolescent will be added to the PBR and provided with information about local providers that are qualified to treat their diagnosis. Each subject can elect to be notified about future research studies s/he may qualify for. Furthermore, the investigators will provide ongoing newsletters with useful information that addresses the latest research underway in the field with the families. If requested, the investigators will provide a written report to their current provider detailing our evaluation. The potential for a breach in confidentiality always exists; however, information that is obtained will be stored in password a protected database and locked file drawers in locked offices; data will have identifying information sheered from it to prevent loss of confidentiality, and all staff must sign confidentiality certificates. If child abuse is detected, the research team is obligated to follow mandatory state reporting laws. To the investigators' knowledge, there is no registry for Pediatric Bipolar Disorder in the city of Houston or the state of Texas that provides the comprehensive evaluation that we are proposing for these children and adolescents and their families. Therefore, this will be a novel service within this division that will provide research to families and potential clients for providers managing these families across the State of Texas.

Interventions

None listed

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Observational model
FAMILY_BASED
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

1. Age 6-17 years old at time of initial visit. 2. Any current mood state Diagnosis of a DSM- IV Bipolar Disorder, Type I, Type II and NOS. 3. Offsprings of a parent diagnosed with Bipolar Disorder Type I or Type II.

Exclusion criteria

1. Pervasive Developmental Disorder (PDD) (and/or PDD NOS) 2. Mental Retardation/Intellectual Disability 3. Severe Neurological Disorder that affects cognitive status (e.g., epilepsy, traumatic brain injury, tubular sclerosis). 4. Schizophrenia 5. Uncontrolled or severe medical problem

Design outcomes

Primary

MeasureTime frameDescription
Course of diagnosis (per MINI kid interview)1 yearAIM I: The goal of the Pediatric Bipolar Registry (PBR) is to provide a comprehensive assessment regarding the diagnosis of pediatric bipolar disorder to children and adolescents with any current mood state and/or children/adolescents who are offspring of a parent with bipolar disorder (BD) type I or II. Data collected will be utilized to perform a retrospective chart review to include measure outcomes and de-identified demographic information detailed in the attached case report forms. Each of these steps will allow result in a comprehensive Pediatric Bipolar Registry database.

Secondary

MeasureTime frameDescription
Changes in Young Mania Rating Scale (YMRS) and Childhood Depression Rating Scale (CDRS) scores2 yearsAIM II: In each case where a diagnosis of bipolar disorder I, bipolar disorder II, or bipolar disorder NOS is determined, the child/adolescent will be added to the Pediatric Bipolar Registry (PBR) and provided with information about local providers that are qualified to treat their diagnosis. Each subject can elect to be notified about future research studies s/he may qualify for. Furthermore, we will provide ongoing newsletters with useful information that addresses the latest research underway in the field with the families. If requested, we will provide a written report to their current provider detailing our evaluation.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026