Neurophysiologic Changes in Patients With Bipolar Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 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: November 19, 2013
Last verified: November 2013
  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: 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 ] [ 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: 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
  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
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 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:
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: November 19, 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:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Affective Disorders, Psychotic
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 September 22, 2014