Bipolar DisorderNCT00961935
Pediatric Bipolar Disorder Study at UCLA
An observational study of Bipolar Disorder, run by University of California, Los Angeles at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Bipolar Disorder
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Bipolar Disorder
Who may be able to join
- 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.
Who cannot join
- Lifetime history of mental retardation, autism, or primary diagnosis of psychosis.
- Subject is pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, 90095
About this study
Official title: Examining Neurocognitive Profiles of Bipolar Disorder and Attention-Deficit Hyperactivity Disorder
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).
Read the detailed 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.
- Conditions
- Bipolar Disorder
- Keywords
- bipolar disorder, child bipolar disorder, adolescent bipolar disorder, pediatric bipolar disorder, fMRI, MRI, EEG, neurocognitive tasks
- Medical subject headings
- Bipolar Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startAug 2008
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The State Family Fund
- Responsible party
- Principal investigator, James McCracken, University of California, Los Angeles
- Investigators
- Patricia Walshaw, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961935
- Sponsor's protocol ID
- P50MH077248-02
- Other IDs
- P50MH077248-02, DNBBS B2-MBP
- Status last verified
- Jan 2016
- First submitted
- 18 Aug 2009
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 3806354Bearden 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.
PubMed 11465675Blumberg 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.
PubMed 12796223Carlson GA. Mania and ADHD: comorbidity or confusion. J Affect Disord. 1998 Nov;51(2):177-87. doi: 10.1016/s0165-0327(98)00179-7.
PubMed 10743850Carlson 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.
PubMed 10199100Casey 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.
PubMed 9055518Castellanos 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.
PubMed 7977887Faraone 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.
PubMed 9256584Geller 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.
PubMed 9291717Geller 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.
PubMed 15123490Geller 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.
PubMed 10743841Geller 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.
PubMed 12014591Gruber 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.
PubMed 15488247Kaufman 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.
PubMed 9204677Kent 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.
PubMed 12547289
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Neurocognitive Profiles of Bipolar Disorder and Attention-Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00961935
- Acronym / sponsor ID
- P50MH077248-02
- Conditions
- Bipolar Disorder
- Keywords
- bipolar disorder, child bipolar disorder, adolescent bipolar disorder, pediatric bipolar disorder, fMRI, MRI, EEG, neurocognitive tasks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The State Family Fund
- Study start
- Aug 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Bipolar Disorder
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Lifetime history of mental retardation, autism, or primary diagnosis of psychosis.
- Subject is pregnant or nursing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Background: PubMed 3806354Baron 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.
- Background: PubMed 11465675Bearden 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.
- Background: PubMed 12796223Blumberg 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.
- Background: PubMed 10743850Carlson GA. Mania and ADHD: comorbidity or confusion. J Affect Disord. 1998 Nov;51(2):177-87. doi: 10.1016/s0165-0327(98)00179-7.
- Background: PubMed 10199100Carlson 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.
- Background: PubMed 9055518Casey 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.
- Background: PubMed 7977887Castellanos 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.
- Background: PubMed 9256584Faraone 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.
- Background: PubMed 9291717Geller 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.
- Background: PubMed 15123490Geller 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.
- Background: PubMed 10743841Geller 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.
- Background: PubMed 12014591Geller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Walshaw, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00961935, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.