Clinical trial NCT02360267: Pediatric Bipolar Registry
Official title: Pediatric Bipolar Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Depression
Mania
Psychosis
Keywords: Bipolar Disorder
Pediatric
Offspring
Depression
Mania
Children of parents who suffer from Bipolar disorder
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 334
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: OTHER
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Course of diagnosis (per MINI kid interview)
timeFrame: 1 year
Secondary outcomes:
measure: Changes in Young Mania Rating Scale (YMRS) and Childhood Depression Rating Scale (CDRS) scores
timeFrame: 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT Center of Excellence on Mood Disorders
state: Texas
Study officials:
affiliation: UT Health Science Center at Houston
name: Jair C Soares, MD
role: PRINCIPAL_INVESTIGATOR
References: