Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00961935
Other study ID # P50MH077248-02
Secondary ID P50MH077248-02DN
Status Completed
Phase N/A
First received August 18, 2009
Last updated January 12, 2016
Start date August 2008
Est. completion date September 2011

Study information

Verified date January 2016
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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).


Description:

Children between the ages of 7 and 17 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 2011
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 17 Years
Eligibility 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.

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States UCLA Semel Institute for Neuroscience and Human Behavior Los Angeles California

Sponsors (3)

Lead Sponsor Collaborator
University of California, Los Angeles National Institute of Mental Health (NIMH), The State Family Fund

Country where clinical trial is conducted

United States, 

References & Publications (24)

Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. — View Citation

Bearden CE, Hoffman KM, Cannon TD. The neuropsychology and neuroanatomy of bipolar affective disorder: a critical review. Bipolar Disord. 2001 Jun;3(3):106-50; discussion 151-3. Review. — View Citation

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. — View Citation

Carlson GA. Juvenile mania versus ADHD. J Am Acad Child Adolesc Psychiatry. 1999 Apr;38(4):353-4. — View Citation

Carlson GA. Mania and ADHD: comorbidity or confusion. J Affect Disord. 1998 Nov;51(2):177-87. Review. — View Citation

Casey BJ, Castellanos FX, Giedd JN, Marsh WL, Hamburger SD, Schubert AB, Vauss YC, Vaituzis AC, Dickstein DP, Sarfatti SE, Rapoport JL. Implication of right frontostriatal circuitry in response inhibition and attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 1997 Mar;36(3):374-83. — View Citation

Castellanos FX, Giedd JN, Eckburg P, Marsh WL, Vaituzis AC, Kaysen D, Hamburger SD, Rapoport JL. Quantitative morphology of the caudate nucleus in attention deficit hyperactivity disorder. Am J Psychiatry. 1994 Dec;151(12):1791-6. — View Citation

Faraone SV, Biederman J, Wozniak J, Mundy E, Mennin D, O'Donnell D. Is comorbidity with ADHD a marker for juvenile-onset mania? J Am Acad Child Adolesc Psychiatry. 1997 Aug;36(8):1046-55. — View Citation

Geller B, Luby J. Child and adolescent bipolar disorder: a review of the past 10 years. J Am Acad Child Adolesc Psychiatry. 1997 Sep;36(9):1168-76. Review. Erratum in: J Am Child Adolesc Psychiatry 1997 Nov;36(11):1642. — View Citation

Geller B, Tillman R, Craney JL, Bolhofner K. Four-year prospective outcome and natural history of mania in children with a prepubertal and early adolescent bipolar disorder phenotype. Arch Gen Psychiatry. 2004 May;61(5):459-67. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kent L, Craddock N. Is there a relationship between attention deficit hyperactivity disorder and bipolar disorder? J Affect Disord. 2003 Feb;73(3):211-21. — View Citation

Kovatchev B, Cox D, Hill R, Reeve R, Robeva R, Loboschefski T. A psychophysiological marker of attention deficit/hyperactivity disorder (ADHD)--defining the EEG consistency index. Appl Psychophysiol Biofeedback. 2001 Jun;26(2):127-40. — View Citation

Mostofsky SH, Cooper KL, Kates WR, Denckla MB, Kaufmann WE. Smaller prefrontal and premotor volumes in boys with attention-deficit/hyperactivity disorder. Biol Psychiatry. 2002 Oct 15;52(8):785-94. — View Citation

National Institute of Mental Health research roundtable on prepubertal bipolar disorder. J Am Acad Child Adolesc Psychiatry. 2001 Aug;40(8):871-8. Review. — View Citation

Pennington BF, Ozonoff S. Executive functions and developmental psychopathology. J Child Psychol Psychiatry. 1996 Jan;37(1):51-87. Review. — View Citation

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

Sax KW, Strakowski SM, Zimmerman ME, DelBello MP, Keck PE Jr, Hawkins JM. Frontosubcortical neuroanatomy and the continuous performance test in mania. Am J Psychiatry. 1999 Jan;156(1):139-41. — View Citation

Walcott CM, Landau S. The relation between disinhibition and emotion regulation in boys with attention deficit hyperactivity disorder. J Clin Child Adolesc Psychol. 2004 Dec;33(4):772-82. — View Citation

Wilder-Willis KE, Sax KW, Rosenberg HL, Fleck DE, Shear PK, Strakowski SM. Persistent attentional dysfunction in remitted bipolar disorder. Bipolar Disord. 2001 Apr;3(2):58-62. — View Citation

Wozniak J, Biederman J, Kiely K, Ablon JS, Faraone SV, Mundy E, Mennin D. Mania-like symptoms suggestive of childhood-onset bipolar disorder in clinically referred children. J Am Acad Child Adolesc Psychiatry. 1995 Jul;34(7):867-76. — View Citation

* Note: There are 24 references in allClick here to view all references

See also
  Status Clinical Trial Phase
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT02855762 - Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder N/A
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Completed NCT02513654 - Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects Phase 1
Recruiting NCT06313918 - Exercise Therapy in Mental Disorders-study N/A
Completed NCT02304432 - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine Early Phase 1
Recruiting NCT06197048 - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder N/A
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT02212041 - Electronic Cigarettes in Smokers With Mental Illness N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Active, not recruiting NCT03641300 - Efficacy of Convulsive Therapies for Bipolar Depression N/A
Not yet recruiting NCT04432116 - Time and Virtual Reality in Schizophrenia and Bipolar Disorder N/A
Terminated NCT02909504 - Gao NARASD Lithium Study Phase 4
Terminated NCT02893371 - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Completed NCT02970721 - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Recruiting NCT03088657 - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
Recruiting NCT02481245 - BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study Phase 2