Neurophysiologic Changes in Patients With Bipolar Depression
NCT ID: NCT01213121
Last Updated: 2013-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2010-09-30
2015-10-31
Brief Summary
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* To examine within-subject changes in neurophysiologic parameters in patients with bipolar depression treated with quetiapine
Detailed Description
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* Depressive phase of bipolar disorder shows multi-faceted characteristics different from unipolar depression
* Quetiapine is an atypical antipsychotic licensed for treatment of bipolar depression
* The aim of this study is to investigate the pattern of neurophysiologic dysregulation in bipolar depression and its changes induced by quetiapine treatment
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
FACTORIAL
BASIC_SCIENCE
NONE
Study Groups
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bipolar depression
unmedicated patients with bipolar depression receiving quetiapine treatment
Quetiapine
oral tablet/25-600mg per day/once a day/six weeks
Control
healthy controls matched for age, gender, and body mass index
No interventions assigned to this group
Interventions
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Quetiapine
oral tablet/25-600mg per day/once a day/six weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Depressive phase
* Drug-naive or drug-free
Exclusion Criteria
* DSM-IV substance-related disorders (within 12 months prior to participation)
* Mentally retarded
18 Years
50 Years
ALL
Yes
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Jae Seung Chang
Clinical Assistant Professor
Principal Investigators
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Jae Seung Chang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Department of Neuropsychiatry, Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Jae Seung Chang, M.D., Ph.D.
Role: primary
Ji Sun Kim, M.D.
Role: backup
References
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Berger S, Boettger MK, Tancer M, Guinjoan SM, Yeragani VK, Bar KJ. Reduced cardio-respiratory coupling indicates suppression of vagal activity in healthy relatives of patients with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Mar 17;34(2):406-11. doi: 10.1016/j.pnpbp.2010.01.009. Epub 2010 Jan 18.
Bar KJ, Schuhmacher A, Hofels S, Schulz S, Voss A, Yeragani VK, Maier W, Zobel A. Reduced cardio-respiratory coupling after treatment with nortriptyline in contrast to S-citalopram. J Affect Disord. 2010 Dec;127(1-3):266-73. doi: 10.1016/j.jad.2010.05.010. Epub 2010 Jun 9.
Chang JS, Yoo CS, Yi SH, Hong KH, Oh HS, Hwang JY, Kim SG, Ahn YM, Kim YS. Differential pattern of heart rate variability in patients with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Aug 31;33(6):991-5. doi: 10.1016/j.pnpbp.2009.05.004. Epub 2009 May 7.
Kemp AH, Quintana DS, Gray MA, Felmingham KL, Brown K, Gatt JM. Impact of depression and antidepressant treatment on heart rate variability: a review and meta-analysis. Biol Psychiatry. 2010 Jun 1;67(11):1067-74. doi: 10.1016/j.biopsych.2009.12.012. Epub 2010 Feb 6.
Kemp AH, Gray MA, Silberstein RB, Armstrong SM, Nathan PJ. Augmentation of serotonin enhances pleasant and suppresses unpleasant cortical electrophysiological responses to visual emotional stimuli in humans. Neuroimage. 2004 Jul;22(3):1084-96. doi: 10.1016/j.neuroimage.2004.03.022.
Related Links
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Click here for more information about recent updates on bipolar disorder research
Other Identifiers
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SNUBH 11-2010-040
Identifier Type: -
Identifier Source: org_study_id