Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 6:03 AM
Study NCT ID:
NCT00961935
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2009-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Bipolar Disorder Study at UCLA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-12', 'studyFirstSubmitDate': '2009-08-18', 'studyFirstSubmitQcDate': '2009-08-18', 'lastUpdatePostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bipolar disorder', 'child bipolar disorder', 'adolescent bipolar disorder', 'pediatric bipolar disorder', 'fMRI', 'MRI', 'EEG', 'neurocognitive tasks'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '3806354', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1037//0022-3514.51.6.1173.'}, {'pmid': '11465675', 'type': 'BACKGROUND', '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. doi: 10.1034/j.1399-5618.2001.030302.x.'}, {'pmid': '12796223', 'type': 'BACKGROUND', '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. doi: 10.1001/archpsyc.60.6.601.'}, {'pmid': '10743850', 'type': 'BACKGROUND', 'citation': 'Carlson GA. Mania and ADHD: comorbidity or confusion. J Affect Disord. 1998 Nov;51(2):177-87. doi: 10.1016/s0165-0327(98)00179-7.'}, {'pmid': '10199100', 'type': 'BACKGROUND', 'citation': 'Carlson GA. Juvenile mania versus ADHD. J Am Acad Child Adolesc Psychiatry. 1999 Apr;38(4):353-4. doi: 10.1097/00004583-199904000-00001. No abstract available.'}, {'pmid': '9055518', 'type': 'BACKGROUND', '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. doi: 10.1097/00004583-199703000-00016.'}, {'pmid': '7977887', 'type': 'BACKGROUND', '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. doi: 10.1176/ajp.151.12.1791.'}, {'pmid': '9256584', 'type': 'BACKGROUND', '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. doi: 10.1097/00004583-199708000-00012."}, {'pmid': '9291717', 'type': 'BACKGROUND', '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. doi: 10.1097/00004583-199709000-00008.'}, {'pmid': '15123490', 'type': 'BACKGROUND', '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. doi: 10.1001/archpsyc.61.5.459.'}, {'pmid': '10743841', 'type': 'BACKGROUND', '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. doi: 10.1016/s0165-0327(98)00175-x.'}, {'pmid': '12014591', 'type': 'BACKGROUND', '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. doi: 10.1089/10445460252943533.'}, {'pmid': '15488247', 'type': 'BACKGROUND', '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. doi: 10.1016/j.jad.2003.10.010.'}, {'pmid': '9204677', 'type': 'BACKGROUND', '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. doi: 10.1097/00004583-199707000-00021.'}, {'pmid': '12547289', 'type': 'BACKGROUND', '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. doi: 10.1016/s0165-0327(02)00092-7.'}, {'pmid': '11480163', 'type': 'BACKGROUND', '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. doi: 10.1023/a:1011339206875.'}, {'pmid': '12372650', 'type': 'BACKGROUND', '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. doi: 10.1016/s0006-3223(02)01412-9.'}, {'pmid': '11501685', 'type': 'BACKGROUND', 'citation': 'National Institute of Mental Health research roundtable on prepubertal bipolar disorder. J Am Acad Child Adolesc Psychiatry. 2001 Aug;40(8):871-8. doi: 10.1097/00004583-200108000-00007.'}, {'pmid': '12450638', 'type': 'BACKGROUND', 'citation': 'Quraishi S, Frangou S. Neuropsychology of bipolar disorder: a review. J Affect Disord. 2002 Dec;72(3):209-26. doi: 10.1016/s0165-0327(02)00091-5.'}, {'pmid': '8655658', 'type': 'BACKGROUND', 'citation': 'Pennington BF, Ozonoff S. Executive functions and developmental psychopathology. J Child Psychol Psychiatry. 1996 Jan;37(1):51-87. doi: 10.1111/j.1469-7610.1996.tb01380.x.'}, {'pmid': '9892312', 'type': 'BACKGROUND', '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. doi: 10.1176/ajp.156.1.139.'}, {'pmid': '15498744', 'type': 'BACKGROUND', '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. doi: 10.1207/s15374424jccp3304_12.'}, {'pmid': '11333063', 'type': 'BACKGROUND', '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. doi: 10.1034/j.1399-5618.2001.030202.x.'}, {'pmid': '7649957', 'type': 'BACKGROUND', '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. doi: 10.1097/00004583-199507000-00010.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Bipolar Disorder', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject suffers clinically impairing symptoms of mood lability.\n* Child has resided with primary caretaker for at least 6 months.\n* Caretaker speaks sufficient English to complete all study evaluations and measures.\n\nExclusion Criteria:\n\n* Lifetime history of mental retardation, autism, or primary diagnosis of psychosis.\n* Subject is pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT00961935', 'briefTitle': 'Pediatric Bipolar Disorder Study at UCLA', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Examining Neurocognitive Profiles of Bipolar Disorder and Attention-Deficit Hyperactivity Disorder', 'orgStudyIdInfo': {'id': 'P50MH077248-02', 'link': 'https://reporter.nih.gov/quickSearch/P50MH077248-02', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'P50MH077248-02', 'link': 'https://reporter.nih.gov/quickSearch/P50MH077248-02', 'type': 'NIH'}, {'id': 'DNBBS B2-MBP', 'type': 'OTHER_GRANT', 'domain': 'National Institute of Mental Health'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Semel Institute for Neuroscience and Human Behavior', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Patricia Walshaw, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'The State Family Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair', 'investigatorFullName': 'James McCracken', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}