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Neurophysiologic Changes in Patients With Bipolar Depression

This study is currently recruiting participants.
Verified April 2013 by Seoul National University Bundang Hospital
Sponsor:
Information provided by (Responsible Party):
Jae Seung Chang, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01213121
First received: September 30, 2010
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose
  • 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

Condition Intervention Phase
Bipolar Depression
 Drug: Quetiapine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Exploring Alterations of Central Autonomic Modulation in Patients With Bipolar Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Heart Rate Variability [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
    heart rate variability parameters of time/frequency/complexity domains


Secondary Outcome Measures:
  • Cardio-Respiratory Coupling [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
    integrative parameters of interaction between neurocardiac dynamics and respiratory rhythm

  • Electroencephalographic Changes [ Time Frame: Six weeks ] [ Designated as safety issue: Yes ]
    Electrical brain activities measured by quantitative electroencephalography

  • Severity of Mood Symptoms [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: Yes ]
    Drug-Induced Extrapyramidal Symptom Scale


Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bipolar depression
unmedicated patients with bipolar depression receiving quetiapine treatment
 Drug: Quetiapine
oral tablet/25-600mg per day/once a day/six weeks
Other Name: Seroquel

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01213121

Contacts
Contact: Jae Seung Chang, M.D., Ph.D. 82-31-787-7437 cjs0107@snu.ac.kr
Contact: Ji Sun Kim, M.D. 82-10-9933-1286 ideal91@hanmail.net

Locations
Korea, Republic of
Department of Neuropsychiatry, Seoul National University Bundang Hospital Recruiting
Seongnam-Si, Gyeonggi-Do, Korea, Republic of, 463-707
Contact: Jae Seung Chang, M.D., Ph.D.     82-31-787-7437     cjs0107@snu.ac.kr    
Contact: Ji Sun Kim, M.D.     82-10-9933-1286     ideal91@hanmail.net    
Sub-Investigator: Ju Young Her, M.S.            
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Jae Seung Chang, M.D., Ph.D. Seoul National University Bundang Hospital
  More Information

Additional Information:
Click here for more information about recent updates on bipolar disorder research  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Jae Seung Chang, Clinical Assistant Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01213121     History of Changes
Other Study ID Numbers: SNUBH 11-2010-040
Study First Received: September 30, 2010
Last Updated: April 12, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
bipolar depression
heart rate variability
cardio-respiratory coupling
electroencephalography

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 17, 2013