search
Back to results

Biological Markers of Response to Treatment in Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
open-label selective serotonin reuptake inhibitor (SSRI)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, biology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ages 18-65 Meet criteria for current Major Depressive Disorder Antidepressant medication-free for at least 2 weeks prior to the start of the study Exclusion Criteria: Pregnant or breastfeeding women Anyone who is suicidal Anyone with an unstable medical condition (cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological), substance abuse problem within the past 6 months, psychoses (past or current), hypothyroidism, or hypomania Anyone currently taking an SSRI Past intolerance to Lexapro or Celexa

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    open-label selective serotonin reuptake inhibitor (SSRI)

    Arm Description

    citalopram or escitalopram

    Outcomes

    Primary Outcome Measures

    Serum Brain-derived Neurotrophic Factor (BDNF) Levels
    "Pre-SSRI BDNF Level" refers to the data collection point before SSRI intake and "Post-SSRI BDNF Level" refers to the data collection point 8 weeks after SSRI intake.
    Quantitative Electroencephalogram (QEEG) Parameters as Predictors of Response
    Pre-treatment quantitative electroencephalogram (QEEG) refers to the data collection point before selective serotonin reuptake inhibitor (SSRI) treatment and Post-treatment QEEG refers to the data collection point 8 weeks after SSRI treatment initiation. Response refers to a greater than 50% decrease in Hamiton Depression Rating Scale from baseline, which ranges from 0 (no depression) to a maximum of 54 (severe depression).

    Secondary Outcome Measures

    Full Information

    First Posted
    August 4, 2006
    Last Updated
    April 10, 2018
    Sponsor
    Massachusetts General Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00361218
    Brief Title
    Biological Markers of Response to Treatment in Major Depressive Disorder
    Official Title
    Serum Brain-Derived Neurotrophic Factor (BDNF) and QEEG as Biological Markers of Response to (Es)Citalopram Treatment in Major Depressive Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2005 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to find out if two tests are useful in predicting whether someone with depression will get better when he or she is treated with an FDA approved antidepressant medication (either citalopram or escitalopram).
    Detailed Description
    Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. In addition, they often experience sleep disruption, loss of appetite, and chronic pain. It often takes several weeks to find out if an antidepressant medication is going to work for someone. This research study aims to identify tests that are able to predict if a medication will work, even before a person starts to feel better. The first test is a measurement of the blood protein Brain-Derived Neurotrophic Factor (BDNF), which is involved with brain cell growth. The second test is a Quantitative Electroencephalogram (QEEG), which measures brain activity. The study lasts for 8 weeks and involves 5 total visits to the clinic. Throughout the study, all subjects will receive either escitalopram (Lexapro) or citalopram (Celexa) on the basis of the study doctor's clinical judgment. The dose of the medications can be increased at any point in time if the study doctor thinks it is appropriate. After the first screen visit (which lasts about 3 hours), each subsequent half-hour visit will involve a 2-tablespoon blood draw to measure BDNF levels, as well as a QEEG in which small, painless electrodes are stuck to the subject's forehead and electrical activity of the brain is measured. At the end of the 8 weeks, subjects are offered 3 months of free follow-up care, including medications.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder
    Keywords
    depression, biology

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    open-label selective serotonin reuptake inhibitor (SSRI)
    Arm Type
    Other
    Arm Description
    citalopram or escitalopram
    Intervention Type
    Drug
    Intervention Name(s)
    open-label selective serotonin reuptake inhibitor (SSRI)
    Other Intervention Name(s)
    escitalopram or citalopram
    Intervention Description
    Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion.
    Primary Outcome Measure Information:
    Title
    Serum Brain-derived Neurotrophic Factor (BDNF) Levels
    Description
    "Pre-SSRI BDNF Level" refers to the data collection point before SSRI intake and "Post-SSRI BDNF Level" refers to the data collection point 8 weeks after SSRI intake.
    Time Frame
    8 weeks
    Title
    Quantitative Electroencephalogram (QEEG) Parameters as Predictors of Response
    Description
    Pre-treatment quantitative electroencephalogram (QEEG) refers to the data collection point before selective serotonin reuptake inhibitor (SSRI) treatment and Post-treatment QEEG refers to the data collection point 8 weeks after SSRI treatment initiation. Response refers to a greater than 50% decrease in Hamiton Depression Rating Scale from baseline, which ranges from 0 (no depression) to a maximum of 54 (severe depression).
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ages 18-65 Meet criteria for current Major Depressive Disorder Antidepressant medication-free for at least 2 weeks prior to the start of the study Exclusion Criteria: Pregnant or breastfeeding women Anyone who is suicidal Anyone with an unstable medical condition (cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological), substance abuse problem within the past 6 months, psychoses (past or current), hypothyroidism, or hypomania Anyone currently taking an SSRI Past intolerance to Lexapro or Celexa
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Denninger, MD, PhD
    Organizational Affiliation
    Depression Clinical and Research Program, Massachusetts General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Biological Markers of Response to Treatment in Major Depressive Disorder

    We'll reach out to this number within 24 hrs