Neurophysiologic Changes in Patients With Bipolar Depression

Overview

– 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

Full Title of Study: “Exploring Alterations of Central Autonomic Modulation in Patients With Bipolar Depression”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

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

Interventions

  • Drug: Quetiapine
    • oral tablet/25-600mg per day/once a day/six weeks

Arms, Groups and Cohorts

  • Experimental: bipolar depression
    • unmedicated patients with bipolar depression receiving quetiapine treatment
  • No Intervention: Control
    • healthy controls matched for age, gender, and body mass index

Clinical Trial Outcome Measures

Primary Measures

  • Heart Rate Variability
    • Time Frame: Six weeks
    • heart rate variability parameters of time/frequency/complexity domains

Secondary Measures

  • Cardio-Respiratory Coupling
    • Time Frame: Six weeks
    • integrative parameters of interaction between neurocardiac dynamics and respiratory rhythm
  • Electroencephalographic Changes
    • Time Frame: Six weeks
    • Electrical brain activities measured by quantitative electroencephalography
  • Severity of Mood Symptoms
    • Time Frame: Six weeks
    • Hamilton Depression Rating Scale Bipolar Depression Rating Scale Young Mania Rating Scale Difficulties in Emotion Regulation Scale Emotion Regulation Questionnaire
  • Severity of Extrapyramidal Symptom Scale
    • Time Frame: Six weeks
    • Drug-Induced Extrapyramidal Symptom Scale

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seoul National University Bundang Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jae Seung Chang, Clinical Assistant Professor – Seoul National University Bundang Hospital
  • Overall Official(s)
    • Jae Seung Chang, M.D., Ph.D., Principal Investigator, Seoul National University Bundang Hospital
  • Overall Contact(s)
    • Jae Seung Chang, M.D., Ph.D., 82-31-787-7437, cjs0107@snu.ac.kr

References

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.

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