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Trial record 45 of 534 for:    ESCITALOPRAM AND Disorders

Electrophysiologic Parameters and Biomarkers Predicting Treatment Response in Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01997580
Recruitment Status : Unknown
Verified November 2013 by Jae Seung Chang, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : November 28, 2013
Last Update Posted : November 28, 2013
Sponsor:
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Jae Seung Chang, Seoul National University Bundang Hospital

Brief Summary:
To explore electrophysiologic parameters and biomarkers predicting treatment response of patients with major depressive disorder To explore electrophysiologic parameters and biomarkers predicting suicide risk of patients with major depressive disorder

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: escitalopram Phase 4

Detailed Description:
Case-control study Repeated measures design

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 4 Study of Escitalopram Treatment and Biomarkers in Major Depressive Disorder
Study Start Date : July 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Escitalopram
depressed patients receiving escitalopram treatment
Drug: escitalopram
SSRI antidepressant
Other Name: lexapro

No Intervention: Control
healthy controls matched for age, gender, and BMI



Primary Outcome Measures :
  1. Change in baseline frequency of maximum of cross-spectrum during 6 weeks (Hz) [ Time Frame: 0, 3, 7, 14, and 42 days ]
    the link between the normalized high frequency component of heart rate variability (HRV-HFnu) representing cardiac vagal modulation and frontal alpha power related to resting state


Secondary Outcome Measures :
  1. Change in cardiorespiratory coupling during 6 weeks [ Time Frame: 0, 3, 7, 14, and 42 days ]
    change in value of cross-sample entropy measured by combining sample entropies of heart rate and respiration

  2. Change in HF during 6 weeks [ Time Frame: 0, 3, 7, 14, and 42 days ]
    change in high frequency component of heart rate variability

  3. Change in persistent homology during 6 weeks [ Time Frame: 0, 3, 7, 14, and 42 days ]
    change in disconnection pattern of EEG channel activities measured by Euclidean distance during 6 weeks



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • DSM-IV-TR major depressive disorder
  • aged between 20 and 80
  • durg-naive or drug-free

Exclusion Criteria:

  • DSM-IV-TR substance-related disorders (except nicotine)
  • significant medical or neurological conditions
  • mental retardation or organic brain damage

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): NCT01997580


Contacts
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Contact: Jae Seung Chang, MD, PhD 82-31-787-7437 cjs0107@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Contact: Jae Seung Chang, MD, PhD    82-31-787-7437    cjs0107@gmail.com   
Sub-Investigator: Meerae Lim, MD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Ministry of Health & Welfare, Korea
Investigators
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Principal Investigator: Jae Seung Chang, MD, PhD Seoul National University Bundang Hospital

Additional Information:
Publications:
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Responsible Party: Jae Seung Chang, Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01997580     History of Changes
Other Study ID Numbers: A121987
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: November 28, 2013
Last Verified: November 2013

Keywords provided by Jae Seung Chang, Seoul National University Bundang Hospital:
depression
treatment
electrophysiology
biomarker

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Depression
Pathologic Processes
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents