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Biological Markers of Response to Treatment in Major Depressive Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00361218
First Posted: August 8, 2006
Last Update Posted: September 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John W. Denninger, MD, PhD, Massachusetts General Hospital
  Purpose
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 Intervention Phase
Major Depressive Disorder Drug: open-label selective serotonin reuptake inhibitor (SSRI) Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by John W. Denninger, MD, PhD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Quantitative Electroencephalogram Measurements [ Time Frame: 8 weeks ]
  • Serum Brain-derived Neurotrophic Factor (BDNF) Levels [ Time Frame: 8 weeks ]

Enrollment: 72
Study Start Date: October 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
open-label 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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
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
Principal Investigator: John Denninger, MD, PhD Depression Clinical and Research Program, Massachusetts General Hospital
  More Information

Additional Information:
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 Submitted: August 4, 2006
First Posted: August 8, 2006
Results First Submitted: July 24, 2013
Results First Posted: September 26, 2013
Last Update Posted: September 26, 2013
Last Verified: July 2013

Keywords provided by John W. Denninger, MD, PhD, Massachusetts General Hospital:
depression
biology

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Serotonin Uptake Inhibitors
Dexetimide
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