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Neurophysiologic Changes in Patients With Bipolar Depression

Primary Purpose

Bipolar Depression

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Quetiapine
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bipolar Depression focused on measuring bipolar depression, heart rate variability, cardio-respiratory coupling, electroencephalography

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Neuropsychiatry, Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

bipolar depression

Control

Arm Description

unmedicated patients with bipolar depression receiving quetiapine treatment

healthy controls matched for age, gender, and body mass index

Outcomes

Primary Outcome Measures

Heart Rate Variability
heart rate variability parameters of time/frequency/complexity domains

Secondary Outcome Measures

Cardio-Respiratory Coupling
integrative parameters of interaction between neurocardiac dynamics and respiratory rhythm
Electroencephalographic Changes
Electrical brain activities measured by quantitative electroencephalography
Severity of Mood Symptoms
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
Drug-Induced Extrapyramidal Symptom Scale

Full Information

First Posted
September 30, 2010
Last Updated
November 19, 2013
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01213121
Brief Title
Neurophysiologic Changes in Patients With Bipolar Depression
Official Title
Exploring Alterations of Central Autonomic Modulation in Patients With Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
bipolar depression, heart rate variability, cardio-respiratory coupling, electroencephalography

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bipolar depression
Arm Type
Experimental
Arm Description
unmedicated patients with bipolar depression receiving quetiapine treatment
Arm Title
Control
Arm Type
No Intervention
Arm Description
healthy controls matched for age, gender, and body mass index
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Other Intervention Name(s)
Seroquel
Intervention Description
oral tablet/25-600mg per day/once a day/six weeks
Primary Outcome Measure Information:
Title
Heart Rate Variability
Description
heart rate variability parameters of time/frequency/complexity domains
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
Cardio-Respiratory Coupling
Description
integrative parameters of interaction between neurocardiac dynamics and respiratory rhythm
Time Frame
Six weeks
Title
Electroencephalographic Changes
Description
Electrical brain activities measured by quantitative electroencephalography
Time Frame
Six weeks
Title
Severity of Mood Symptoms
Description
Hamilton Depression Rating Scale Bipolar Depression Rating Scale Young Mania Rating Scale Difficulties in Emotion Regulation Scale Emotion Regulation Questionnaire
Time Frame
Six weeks
Title
Severity of Extrapyramidal Symptom Scale
Description
Drug-Induced Extrapyramidal Symptom Scale
Time Frame
Six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Seung Chang, M.D., Ph.D.
Phone
82-31-787-7437
Email
cjs0107@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Sun Kim, M.D.
Phone
82-10-9933-1286
Email
ideal91@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Seung Chang, M.D., Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neuropsychiatry, Seoul National University Bundang Hospital
City
Seongnam-Si
State/Province
Gyeonggi-Do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Seung Chang, M.D., Ph.D.
Phone
82-31-787-7437
Email
cjs0107@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Ji Sun Kim, M.D.
Phone
82-10-9933-1286
Email
ideal91@hanmail.net
First Name & Middle Initial & Last Name & Degree
Ju Young Her, M.S.

12. IPD Sharing Statement

Citations:
PubMed Identifier
20083149
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.
Results Reference
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PubMed Identifier
20538342
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.
Results Reference
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PubMed Identifier
19427888
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.
Results Reference
background
PubMed Identifier
20138254
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.
Results Reference
background
PubMed Identifier
15219580
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.
Results Reference
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Links:
URL
http://www.nimh.nih.gov/trials/bipolar-disorder-manic-depressive-illness.shtml
Description
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Neurophysiologic Changes in Patients With Bipolar Depression

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