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Completed

NCT Number: NCT02360267

Pediatric Bipolar Registry

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pervasive Developmental Disorder (PDD) (and/or PDD NOS)
  • 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

Treatment and study plan

Primary outcomes

  1. Course of diagnosis (per MINI kid interview)

    Time frame: 1 year

    AIM 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 outcomes

  1. Changes in Young Mania Rating Scale (YMRS) and Childhood Depression Rating Scale (CDRS) scores

    Time frame: 2 years

    AIM 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Acronym: PBR

Important dates

Study start
2013
Primary completion
2016
Study completion
2019
First posted
Feb 10, 2015
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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