Neurophysiologic Changes in Patients With Bipolar Depression

Study Overview
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Brief Summary
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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
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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

Official Title
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Exploring Alterations of Central Autonomic Modulation in Patients With Bipolar Depression

Conditions
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Bipolar Depression

Intervention / Treatment
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* Drug: Quetiapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bipolar depression<br>unmedicated patients with bipolar depression receiving quetiapine treatment | Drug: Quetiapine<br>* oral tablet/25-600mg per day/once a day/six weeks<br>* Other names: Seroquel;|
| No Intervention: Control<br>healthy controls matched for age, gender, and body mass index | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bipolar depression, heart rate variability, cardio-respiratory coupling, electroencephalography