Pediatric Bipolar Registry

NCT02360267 | Completed

• 1 other identifier: HSC-MS-12-0673
• Study Type: observational
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Depression; Mania; Psychosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Course of diagnosis (per MINI kid interview)

  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 Outcomes (1)

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

  2 years

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

UT Center of Excellence on Mood Disorders

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Depression; Mania; Psychotic Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Jair C Soares, MD

  UT Health Science Center at Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Principal Investigator

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 10, 2015
• Study Start: August 5, 2013
• Primary Completion: May 1, 2016
• Study Completion: February 1, 2019
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

US (1)