Neurophysiologic Changes in Patients With Bipolar Depression

November 19, 2013 updated by: Jae Seung Chang, Seoul National University Bundang Hospital

Exploring Alterations of Central Autonomic Modulation in Patients With Bipolar Depression

  • 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-Do
      • Seongnam-Si, Gyeonggi-Do, Korea, Republic of, 463-707
        • Recruiting
        • Department of Neuropsychiatry, Seoul National University Bundang Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ju Young Her, M.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Seroquel
No Intervention: Control
healthy controls matched for age, gender, and body mass index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: Six weeks
heart rate variability parameters of time/frequency/complexity domains
Six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardio-Respiratory Coupling
Time Frame: Six weeks
integrative parameters of interaction between neurocardiac dynamics and respiratory rhythm
Six weeks
Electroencephalographic Changes
Time Frame: Six weeks
Electrical brain activities measured by quantitative electroencephalography
Six weeks
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
Six weeks
Severity of Extrapyramidal Symptom Scale
Time Frame: Six weeks
Drug-Induced Extrapyramidal Symptom Scale
Six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Jae Seung Chang, M.D., Ph.D., Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

September 30, 2010

First Submitted That Met QC Criteria

September 30, 2010

First Posted (Estimate)

October 1, 2010

Study Record Updates

Last Update Posted (Estimate)

November 21, 2013

Last Update Submitted That Met QC Criteria

November 19, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH 11-2010-040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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