Neurophysiologic Changes in Patients With Bipolar Depression

Phase 4

• Conditions: Bipolar Depression
• Interventions: Drug: Quetiapine

• Registration Number: NCT01213121
• Lead Sponsor: 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

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-09-30
• Study First Posted: 2010-10-01
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-19
• Last Update Posted: 2013-11-21
• Primary Completion: 2014-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• DSM-IV bipolar disorder I or II
• Depressive phase
• Drug-naive or drug-free

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Exclusion Criteria

• Serious medical or neurological conditions
• DSM-IV substance-related disorders (within 12 months prior to participation)
• Mentally retarded

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
bipolar depression	Quetiapine	unmedicated patients with bipolar depression receiving quetiapine treatment

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability	Six weeks	heart rate variability parameters of time/frequency/complexity domains

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Neuropsychiatry, Seoul National University Bundang Hospital; 🇰🇷 Seongnam-Si, Gyeonggi-Do, Korea, Republic of