Pediatric Bipolar Registry (PBR)

June 17, 2025 updated by: Jair Soares, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

334

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77054
        • UT Center of Excellence on Mood Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children ages 6-17 who may suffer from Bipolar Disorder (BP I, BP II, or BP-NOS) or whose parents suffer from Bipolar Disorder (BP I or BP II).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Jair C Soares, MD, UT Health Science Center at Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

February 2, 2015

First Submitted That Met QC Criteria

February 4, 2015

First Posted (Estimated)

February 10, 2015

Study Record Updates

Last Update Posted (Actual)

June 22, 2025

Last Update Submitted That Met QC Criteria

June 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-12-0673

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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