Clinical trial NCT01213121: Neurophysiologic Changes in Patients With Bipolar Depression
Official title: Exploring Alterations of Central Autonomic Modulation in Patients With Bipolar Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bipolar Depression
Keywords: bipolar depression
heart rate variability
cardio-respiratory coupling
electroencephalography
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2010-10-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: * To examine differences in neurophysiologic parameters between unmedicated patients with bipolar depression and healthy controls
* To examine within-subject changes in neurophysiologic parameters in patients with bipolar depression treated with quetiapine

Detailed description: * Alterations of neurophysiologic regulation has been suggested in patients with major depressive disorder or bipolar disorders
* 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

Eligibility criteria: Inclusion Criteria:

* DSM-IV bipolar disorder I or II
* Depressive phase
* Drug-naive or drug-free

Exclusion Criteria:

* Serious medical or neurological conditions
* DSM-IV substance-related disorders (within 12 months prior to participation)
* Mentally retarded

Primary outcomes:
measure: Heart Rate Variability
timeFrame: Six weeks
Secondary outcomes:
measure: Cardio-Respiratory Coupling
timeFrame: Six weeks
measure: Electroencephalographic Changes
timeFrame: Six weeks
measure: Severity of Mood Symptoms
timeFrame: Six weeks
measure: Severity of Extrapyramidal Symptom Scale
timeFrame: Six weeks
Other outcomes:
Locations:
city: Seongnam-Si
country: Korea, Republic of
facility: Department of Neuropsychiatry, Seoul National University Bundang Hospital
state: Gyeonggi-Do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jae Seung Chang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.