Exploring Biomarkers for Depression

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Massachusetts General Hospital
Martinos Center for Biomedical Imaging
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Wyss Institute at Harvard University
ClinicalTrials.gov Identifier:
NCT01424111
First received: August 19, 2011
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

The purpose of this research is to explore objective biomarkers in voice, physiological, motor, and brain imaging signals that may one day be used to complement clinical evaluation and treatment of depression.


Condition Intervention
Major Depressive Disorder
Drug: Escitalopram
Other: Healthy Control

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Exploring Biomarkers for Depression

Resource links provided by NLM:


Further study details as provided by Wyss Institute at Harvard University:

Primary Outcome Measures:
  • Objective Biomarkers [ Time Frame: Participants will be followed for an expected average of 9 weeks of data collection. ] [ Designated as safety issue: No ]
    Objective biomarkers in voice, physiological, motor and brain imaging signals


Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment
Those receiving an open-label, 10-20 mg/day, flexible-dose of escitalopram. The treatment period is 8 weeks long.
Drug: Escitalopram
An open-label, 10-20 mg/day, flexible-dose of escitalopram will be administered to all subjects included in this study in the form of tablets. The treatment period is 8 weeks long.
Other Names:
  • Lexapro
  • Cipralex
  • Seroplex
  • Lexamil
  • Lexam
Healthy Control
Those not receiving treatment.
Other: Healthy Control
No Treatment

Detailed Description:

The hypothesis for our work is that dynamical fluctuations of biological signals, such as, voice, video, pulse rate, oxygen saturation, skin temperature, skin conductivity, motor response, magnetoencephalography (MEG), and electroencephalography (EEG), are less complex during depressive than normal phases. There is a great need for objective biomarkers that may complement current clinical measures to help recognize depression, monitor its severity, and quantify the effect of interventions and recovery.

Data will be collected from 20 adult participants seeking outpatient treatment for depression at the Depression and Clinical Research Program at Massachusetts General Hospital (MGH), each participating for a total of approximately 9 weeks. For correlation of findings, data will also be collected from 20 subjects who take part in the healthy/control group. The healthy/control group will participate in a more limited study visit schedule over the course of 9 weeks, and will not be given any treatment. During study visits, the investigators will conduct recordings of voice, video, pulse rate, oxygen saturation, body temperature, skin conductivity, and motor movement at the Department of Psychiatry at MGH. In addition, each subject may participate in MEG, EEG, and Magnetic Resonance Imaging (MRI) brain imaging sessions at the Athinoula A. Martinos Center for Biomedical Engineering.

In order to collect relevant data and correlate findings with accepted clinical measures of depression severity and response to treatment, this study is conducted as a follow-up study in concert with a typical drug treatment protocol for Major Depressive Disorder (MDD). Specifically, our measurements will be made in conjunction with a standard of care drug treatment protocol using the antidepressant medication escitalopram, an FDA-approved selective serotonin re-uptake inhibitor (SSRI) commonly used to treat depression. The data will be collected over a period of approximately 9 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients seeking treatment for Major Depressive Disorder at the Depression Clinical and Research Program at Massachusetts General Hospital. This study also enrolls a limited number of healthy controls.

Criteria

Treatment Group Inclusion Criteria:

  1. Men or women age 18-65;
  2. Written informed consent;
  3. Meet DSM-IV criteria (by Structured Clinical Interview for DSM-IV - SCID-I/P) for current major depressive episode (MDE);
  4. Hamilton Rating Scale for Depression (HAM-D-17) baseline score ≥ 16.

Treatment Group Exclusion Criteria:

  1. Subjects whose first language is not English;
  2. In women, pregnancy, plans to conceive, or unwillingness to comply with birth control requirements;
  3. Subjects with a baseline Clinical Global Impressions-Severity score of 6 or 7;
  4. Subjects with suicidal ideation where outpatient treatment is determined unsafe by the clinician. These subjects will be immediately referred to appropriate clinical treatment;
  5. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease;
  6. History of seizure disorder;
  7. History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months;
  8. Subjects with mood congruent or mood incongruent psychotic features;
  9. Clinical or laboratory evidence of hypothyroidism;
  10. Positive urine drug screen at evaluation visit;
  11. Electro Convulsive Therapy (ECT) during the last year;
  12. Subjects who have failed to respond during the course of their current major depressive episode to a trial of escitalopram (at least 40mg/day for six weeks or more)
  13. History of intolerance to citalopram or escitalopram;
  14. Subjects requiring excluded medications including antidepressants, anorexics, antiarrhythmics, and other psychotropic agents (including lithium, benzodiazepine sedatives, other sedatives, and anti-seizure medications), beta-blockers (such as metoprolol or propranolol) ketoconazole, itraconazole, fluconazole, erythromycin, omeprazole, cimetidine, dehydroepiandrosterone (DHEA), entacapone, hydroxytryptophan (5-HTP), ginkgo, St. John's Wort (hypercium), naratriptan, rizatriptan, sibutramine, zolmitriptan and warfarin (Coumadin).
  15. Subjects who have failed two or more adequate antidepressant trials during the current Major Depressive Episode (MDE)

    If a subject is deemed eligible from the above criteria, there is additional exclusion criteria required to participate in Martinos Center study visits, listed below. Subjects meeting any of the below criteria will not be allowed to participate in visits to the Martinos Center.

  16. Subjects of weight above 300 lbs. (limit for 1.5T Siemens Sonata whole body scanner used in MRI data acquisition);
  17. History of significant head trauma (unconsciousness for 10 minutes or longer);
  18. Surgical aneurysm clips;
  19. Cardiac pacemaker;
  20. Prosthetic heart valve;
  21. Use of a neurostimulator;
  22. Implanted pumps;
  23. Cochlear implants;
  24. Metal rods, plates, or screws in the body, or metal foil medical skin patches that cannot be removed;
  25. IUD;
  26. Previous head surgery;
  27. Hearing aid;
  28. Non-removable dentures, root canals, dental implants, bridges, and wires in the mouth;
  29. Currently breastfeeding;
  30. Meniere's Disease;
  31. Metal (shiny) tattoos or metal body jewelry that cannot be removed;
  32. Claustrophobia;
  33. Abnormal hearing;
  34. Glasses with vision correction greater than +/- 6 diopters.

Healthy/Control Group Inclusion Criteria:

  1. Men or Women, ages 18-65;
  2. Written informed consent;
  3. QIDS-SR score of < 8 at Screening Visit;
  4. Agrees to, and is eligible for, all biomarkers procedures (M/EEG, MRI, physiological recordings);

Healthy/Control Group Exclusion Criteria:

  1. Subjects whose first language is not English;
  2. Current or lifetime history for major depressive disorder, psychotic depression bipolar (I, II, or NOS) 
disorder, schizoaffective disorder, schizophrenia, or other Axis I psychotic disorder;
  3. Meet DSM-IV criteria (by Structured Clinical Interview for DSM-IV - SCID-I/P) for current major depressive episode (MDE);
  4. HAM-D-17 baseline score ≥ 8
  5. Any current Axis I or Axis II diagnoses;
  6. A woman who is pregnant or breastfeeding;
  7. Meeting DSM-IV criteria for substance dependence in the last 6 months, except for nicotine, or 
substance abuse in the last 2 months;
  8. Positive urine drug screen at evaluation visit;
  9. Any current history for an unstable general medical condition (GMC) that requires hospitalization or 
deemed by investigator to be clinically significant;
  10. Any current history for a moderate or severe acute or chronic medical condition that, based on the judgment of the PI or appropriate medical personnel would exclude the subject i.e. epilepsy, unstable hypothyroidism;

    If a subject is deemed eligible from the above criteria, there is additional exclusion criteria required to participate in Martinos Center study visits. Subjects meeting any of the below criteria will not be allowed to participate in visits to the Martinos Center:

  11. Subjects of weight above 300 lbs. (limit for 1.5T Siemens Sonata whole body scanner used in MRI data acquisition);
  12. History of significant head trauma (unconsciousness for 10 minutes or longer);
  13. Surgical aneurysm clips;
  14. Cardiac pacemaker;
  15. Prosthetic heart valve;
  16. Use of a neurostimulator;
  17. Implanted pumps;
  18. Cochlear implants;
  19. Metal rods, plates, or screws in the body, or metal foil medical skin patches that cannot be removed;
  20. IUD;
  21. Previous head surgery;
  22. Hearing aid;
  23. Non-removable dentures, root canals, dental implants, bridges, and wires in the mouth;
  24. Currently breastfeeding;
  25. Meniere's Disease;
  26. Metal (shiny) tattoos or metal body jewelry that cannot be removed;
  27. Claustrophobia;
  28. Abnormal hearing;
  29. Glasses with vision correction greater than +/- 6 diopters.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424111

Locations
United States, Massachusetts
Depression Clinical and Research Program, MGH
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Wyss Institute at Harvard University
Massachusetts General Hospital
Martinos Center for Biomedical Imaging
Massachusetts Institute of Technology
Investigators
Principal Investigator: Andrew Nierenberg, MD DCRP, Massachusetts General Hospital
Principal Investigator: Diana Young, Ph.D Wyss Institute, Harvard University
Principal Investigator: Tommi Raij, MD, Ph.D Martinos Center, Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Wyss Institute at Harvard University
ClinicalTrials.gov Identifier: NCT01424111     History of Changes
Other Study ID Numbers: AMD-CS-0007
Study First Received: August 19, 2011
Last Updated: September 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wyss Institute at Harvard University:
Biomarkers
Depression
Major Depressive Disorder
Escitalopram

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

ClinicalTrials.gov processed this record on October 23, 2014