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Biological Markers of Response to Treatment in Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00361218
Recruitment Status : Completed
First Posted : August 8, 2006
Results First Posted : September 26, 2013
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
John W. Denninger, MD, PhD, Massachusetts General Hospital

Study Description
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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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: open-label selective serotonin reuptake inhibitor (SSRI) Phase 3

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Serum Brain-Derived Neurotrophic Factor (BDNF) and QEEG as Biological Markers of Response to (Es)Citalopram Treatment in Major Depressive Disorder
Study Start Date : October 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
open-label selective serotonin reuptake inhibitor (SSRI)
citalopram or escitalopram
 Drug: open-label selective serotonin reuptake inhibitor (SSRI)
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.
Other Name: escitalopram or citalopram


Outcome Measures
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Primary Outcome Measures :
  1. Serum Brain-derived Neurotrophic Factor (BDNF) Levels [ Time Frame: 8 weeks ]
    "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.

  2. Quantitative Electroencephalogram (QEEG) Parameters as Predictors of Response [ Time Frame: 8 weeks ]

    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).



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT00361218


Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: John Denninger, MD, PhD Depression Clinical and Research Program, Massachusetts General Hospital
More Information
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Additional Information:
Massachusetts General Hospital Depression Clinical and Research Program Website  This link exits the ClinicalTrials.gov site

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Responsible Party: John W. Denninger, MD, PhD, Instructor in Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00361218     History of Changes
Other Study ID Numbers: 2005P000413
First Posted: August 8, 2006    Key Record Dates
Results First Posted: September 26, 2013
Last Update Posted: May 11, 2018
Last Verified: April 2018
Keywords provided by John W. Denninger, MD, PhD, Massachusetts General Hospital:
depression
biology
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
Serotonin Uptake Inhibitors
Serotonin
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
Serotonin Receptor Agonists