Pediatric Bipolar Disorder Study at UCLA - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Collaborator:	The State Family Fund
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00961935

Purpose

The UCLA Semel Institute for Neuroscience in Los Angeles, CA, is conducting a study looking at similarities and differences in how the brain works between bipolar disorder and attention deficit hyperactivity disorder (ADHD).

Condition	Intervention
Bipolar Disorder	Other: Neurocognitive Tasks Other: EEG Other: fMRI

Study Type:	Observational
Study Design:	Cross-Sectional
Official Title:	Examining Neurocognitive Profiles of Bipolar Disorder and Attention-Deficit Hyperactivity Disorder

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Bipolar Disorder

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	August 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Pediatric Bipolar children and adolescents with bipolar disorder	Other: Neurocognitive Tasks Completed during Visit 1. Requires up to 4 hours. No treatment provided. Other: EEG Completed during Visit 2. Requires up to 3 hours. No treatment provided. Other: fMRI Completed during Visit 3. Requires up to 2 hours. No treatment provided.

Detailed Description:

Children between the ages of 7 and 16 years old, with a diagnosis of Bipolar I, Bipolar II, or Bipolar NOS, are currently being recruited for this study looking at similarities and differences in how the brain works between bipolar disorder and attention deficit hyperactivity disorder (ADHD). The study involves a comprehensive evaluation at intake, cognitive assessment, EEG, and functional MRI, done over the course of 2 or 3 visits. Participants will be paid $125 for their participation; parents will be compensated $25 per visit for travel expenses. This study does not provide treatment. However, with participants' consent, the assessment information can be shared with the child's clinician or psychiatrist and a letter with the results from cognitive testing can be prepared, which can be useful in school planning. Referrals for treatment can also be provided.

Eligibility

Ages Eligible for Study:	7 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Community Sample

Criteria

Inclusion Criteria:

Subject suffers clinically impairing symptoms of mood lability.
Child has resided with primary caretaker for at least 6 months.
Caretaker speaks sufficient English to complete all study evaluations and measures.

Exclusion Criteria:

Lifetime history of mental retardation, autism, or primary diagnosis of psychosis.
Subject is pregnant or nursing.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961935

Contacts

Contact: Patricia Walshaw, Ph.D.	310-825-0357	pwalshaw@mednet.ucla.edu
Contact: Rebecca Voaklander	310-825-9818	rvoaklander@mednet.ucla.edu

Locations

United States, California
UCLA Semel Institute for Neuroscience and Human Behavior	Recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Patricia Walshaw, Ph.D.

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

The State Family Fund

Investigators

Principal Investigator:

Patricia Walshaw, Ph.D.

University of California, Los Angeles

More Information

Additional Information:

UCLA Mood Disorders Research Program This link exits the ClinicalTrials.gov site

Publications:

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Blumberg HP, Leung HC, Skudlarski P, Lacadie CM, Fredericks CA, Harris BC, Charney DS, Gore JC, Krystal JH, Peterson BS. A functional magnetic resonance imaging study of bipolar disorder: state- and trait-related dysfunction in ventral prefrontal cortices. Arch Gen Psychiatry. 2003 Jun;60(6):601-9.

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Geller B, Williams M, Zimerman B, Frazier J, Beringer L, Warner KL. Prepubertal and early adolescent bipolarity differentiate from ADHD by manic symptoms, grandiose delusions, ultra-rapid or ultradian cycling. J Affect Disord. 1998 Nov;51(2):81-91.

Geller B, Zimerman B, Williams M, Delbello MP, Bolhofner K, Craney JL, Frazier J, Beringer L, Nickelsburg MJ. DSM-IV mania symptoms in a prepubertal and early adolescent bipolar disorder phenotype compared to attention-deficit hyperactive and normal controls. J Child Adolesc Psychopharmacol. 2002 Spring;12(1):11-25.

Gruber SA, Rogowska J, Yurgelun-Todd DA. Decreased activation of the anterior cingulate in bipolar patients: an fMRI study. J Affect Disord. 2004 Oct 15;82(2):191-201.

Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997 Jul;36(7):980-8.

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[No authors listed] National Institute of Mental Health research roundtable on prepubertal bipolar disorder. J Am Acad Child Adolesc Psychiatry. 2001 Aug;40(8):871-8. Review.

Quraishi S, Frangou S. Neuropsychology of bipolar disorder: a review. J Affect Disord. 2002 Dec;72(3):209-26. Review.

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Responsible Party:	University of California, Los Angeles ( Patricia Walshaw )
Study ID Numbers:	P50 MH077248-02, DNBBS B2-MBP
Study First Received:	August 18, 2009
Last Updated:	September 4, 2009
ClinicalTrials.gov Identifier:	NCT00961935 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

bipolar disorder
child bipolar disorder
adolescent bipolar disorder
pediatric bipolar disorder

fMRI
MRI
EEG
neurocognitive tasks

Additional relevant MeSH terms:

Affective Disorders, Psychotic
Pathologic Processes
Disease
Attention Deficit Disorder with Hyperactivity
Mental Disorders

Bipolar Disorder
Mental Disorders Diagnosed in Childhood
Mood Disorders
Attention Deficit and Disruptive Behavior Disorders

ClinicalTrials.gov processed this record on November 20, 2009