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Neurophysiologic Changes in Patients With Bipolar Depression

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ClinicalTrials.gov Identifier: NCT01213121
Recruitment Status : Unknown
Verified November 2013 by Jae Seung Chang, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : October 1, 2010
Last Update Posted : November 21, 2013
Sponsor:
Information provided by (Responsible Party):
Jae Seung Chang, Seoul National University Bundang Hospital

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

Condition or disease Intervention/treatment Phase
Bipolar Depression Drug: Quetiapine Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exploring Alterations of Central Autonomic Modulation in Patients With Bipolar Depression
Study Start Date : September 2010
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



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


Secondary Outcome Measures :
  1. Cardio-Respiratory Coupling [ Time Frame: Six weeks ]
    integrative parameters of interaction between neurocardiac dynamics and respiratory rhythm

  2. Electroencephalographic Changes [ Time Frame: Six weeks ]
    Electrical brain activities measured by quantitative electroencephalography

  3. 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

  4. Severity of Extrapyramidal Symptom Scale [ Time Frame: Six weeks ]
    Drug-Induced Extrapyramidal Symptom Scale



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 1, 2010    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013

Keywords provided by Jae Seung Chang, 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
Bipolar and Related Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs