Neurophysiologic Changes in Patients With Bipolar Depression

Exploring Alterations of Central Autonomic Modulation in Patients With Bipolar Depression

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01213121

Enrollment

Registered

2010-10-01

Start date

2010-09-30

Completion date

2015-10-31

Last updated

2013-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Depression

Keywords

bipolar depression, heart rate variability, cardio-respiratory coupling, electroencephalography

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

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

Interventions

DRUGQuetiapine

oral tablet/25-600mg per day/once a day/six weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Contacts

Primary ContactJae Seung Chang, M.D., Ph.D.

cjs0107@snu.ac.kr82-31-787-7437

Backup ContactJi Sun Kim, M.D.

ideal91@hanmail.net82-10-9933-1286

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026