Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Neurophysiologic Changes in Patients With Bipolar Depression

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Jae Seung Chang, Seoul National University Bundang Hospital Identifier:
First received: September 30, 2010
Last updated: November 19, 2013
Last verified: November 2013
  • 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: Factorial 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:

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

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

Secondary Outcome 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

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 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
No Intervention: Control
healthy controls matched for age, gender, and body mass index

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

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01213121

Contact: Jae Seung Chang, M.D., Ph.D. 82-31-787-7437
Contact: Ji Sun Kim, M.D. 82-10-9933-1286

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   
Contact: Ji Sun Kim, M.D.    82-10-9933-1286   
Sub-Investigator: Ju Young Her, M.S.         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Principal Investigator: Jae Seung Chang, M.D., Ph.D. Seoul National University Bundang Hospital
  More Information

Additional Information:
Responsible Party: Jae Seung Chang, Clinical Assistant Professor, Seoul National University Bundang Hospital Identifier: NCT01213121     History of Changes
Other Study ID Numbers: SNUBH 11-2010-040
Study First Received: September 30, 2010
Last Updated: November 19, 2013

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

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on May 22, 2017